Apple Watch

The Apple Watch (current Series 11 and Ultra 3, September 2025; Series 9/10 and Ultra 2 supported) is a biometric-primary smartwatch and the canonical reference of the biometric cohort, with the broadest FDA-cleared portfolio: ECG and AFib/irregular-rhythm notifications (De Novo 2018), sleep-apnea notifications (2024), and hypertension notifications (2025), plus fall and crash detection and the Vitals app. Its sensors (optical PPG, electrical ECG, temperature, accelerometer/gyro, blood-oxygen) need no subscription for the FDA-cleared medical features. Pricing anchors at about $399 for the Series base (aluminum, GPS), with the Ultra around $799 and the SE around $249 (the SE lacks ECG). A within-entity verified-vs-claimed exemplar: blood-oxygen was disabled in the US in January 2024 over the Masimo ITC ruling and re-enabled in August 2025 via a paired-iPhone calculation redesign. DEPLOY holds the claims to the specific cleared indications: these are cleared features with defined scope, not a general cardiac or sleep diagnostic.

Readiness

Apple Watch is shipping now at $399-$799 (actual sale price), the 5 capability claims on file are mixed autonomy with verified, 1 verified deployment is on file, and 1 incident is on record.

Availability

shipping-now

Shipping now.

see evidence →

Price honesty

actual-sale-price

One price on file: $399-$799 (actual sale price).

see evidence →

Capability honesty

autonomous

5 reviewed claims, mixed: 3 autonomous, 2 claimed-only.

see evidence →

Real-world use

commercial

Maturity: commercial. 1 verified deployment in the registry.

see evidence →

Safety record

incidents-on-file

1 incident on record across 1 verified deployment.

see evidence →

What it claims to do

• Detects irregular heart rhythmautonomous· verifiedevidence ↗
• Tracks heart healthautonomous· verifiedevidence ↗
• Tracks blood oxygen (SpO2)claimed-only· claimedevidence ↗
• Tracks fitness and activityautonomous· verifiedevidence ↗
• Tracks sleepclaimed-only· claimedevidence ↗

Price

• $399-$799actual sale price · Apple (Apple Watch) ↗ · as of 2025-09-09

Real-world use

• Global

Safety record

• Apple disabled Blood Oxygen on US Apple Watch to comply with a Masimo ITC exclusion order2024-01-18

Privacy

Privacy practices disclosed by Apple for Apple Watch, with verification status.

• Data deletion controlverified

  HealthKit app permissions never expire on their own. One tap of Allow gives an app unlimited read access to all your health history and future data until you manually revoke it. Apps granted access before June 2022 still have it today, and Apple does not remind you when a connected app has not been opened in months.

  Source: Apple Developer: Protecting User Privacy in HealthKit

• Cloud uploadverified

  Health data in iCloud is only end-to-end encrypted if you turn on Advanced Data Protection, which is off by default. Without it, Apple holds decryption keys and complies with government requests. Most users are not protected.

  Source: Apple Support: Advanced Data Protection for iCloud

• Third-party sharingverified

  If you joined an Apple Research study, your ongoing body data goes to universities including Harvard and Michigan, and the NIH. Enrollment continues until you actively quit, and quitting does not delete data already sent.

  Source: Apple Research App overview

• Data retentionverified

  You control how long health data is kept and can edit or delete it anytime. Research study data is automatically and permanently deleted from your device after seven days.

  Source: https://www.apple.com/legal/privacy/data/en/health-app/

• Data saleverified

  Does not sell your health data under any US state privacy law, including California and Nevada.

  Source: https://www.apple.com/legal/privacy/consumer-health-personal-data/en-ww/

• Training data useverified

  If you opt into the Improve Health and Activity program, Apple uses your data to improve health features. This data is aggregated and not tied to you personally, and Apple says it does not train its core AI models on your private health data.

  Source: https://www.apple.com/legal/privacy/data/en/improve-health-activity/

• On-device processingverified

  Key health features including Medications, Mental Health, Siri health requests, Cycle Tracking, and Trends run entirely on your device, so that data does not leave your phone.

  Source: https://www.apple.com/legal/privacy/data/en/health-app/

• Location trackingverified

  Health features may use your region to check availability. If you opt into the Improve Health and Activity program, Apple also collects your approximate location along with workout data.

  Source: https://www.apple.com/legal/privacy/data/en/improve-health-activity/

• Biometric storageverified

  Continuously tracks your heart rhythm, wrist temperature, blood oxygen, breathing, and sleep patterns. When synced to iCloud with two-factor authentication, this data is end-to-end encrypted and Apple cannot read it.

  Source: https://www.apple.com/legal/privacy/data/en/health-app/

• Biometric storageverified

  Apple Watch collects health information relating to physical or mental health status, fitness and exercise details, precise location for Find My and region-specific services, device information including serial number, and usage data about activity on Apple services; biometric data is processed on-device where possible.

  Source: maker privacy policy · 2026-06-17

• Data saleverified

  Apple does not sell your personal data including as sale is defined in Nevada and California; Apple also does not share your personal data as that term is defined in California, and does not share personal data with third parties for their own marketing purposes.

  Source: maker privacy policy · 2026-06-17

• Data deletion controlverified

  Users can access, delete, correct, transfer, and restrict processing of their personal data via the Apple Data and Privacy page at privacy.apple.com; personalized ads can be toggled off in Settings; consent can be withdrawn at any time; parents can manage children's data through the child's account.

  Source: maker privacy policy · 2026-06-17

• Data retentionverified

  Apple retains personal data only for as long as necessary to fulfill the purposes for which it was collected, working to retain data for the shortest possible period permissible under law; Apple uses administrative, technical, and physical safeguards to protect personal data with details in the Apple Platform Security guide.

  Source: maker privacy policy · 2026-06-17

Specs

notes

• FDA clearances (the verification anchor): ECG app + Irregular Rhythm Notification: FDA De Novo Nov 2018 (DEN180044/DEN180042). AFib History: 510(k) Jun 2022 - cleared ONLY for users 22+ ALREADY DIAGNOSED with AFib. Sleep Apnea Notifications: 510(k) Sept 2024 - mod-severe OSA, adults 18+, NOT diagnostic. Hypertension Notifications: cleared Sept 2025 (K250507) - 30-day passive screening, not BP measurement.
• CAP-FLAG (marketing beyond clearance): AFib History is diagnosed-users-only (framing it as detecting NEW AFib exceeds the indication). Sleep-apnea + hypertension features are NOTIFICATION/SCREENING tools, never diagnostic or BP-measurement - any 'blood pressure monitoring' or 'diagnosis' framing exceeds clearance.
• Disabled-feature exemplar (verified-vs-claimed): Blood Oxygen / SpO2 was DISABLED on US units from Jan 17 2024 after the Masimo ITC import ban, then RE-ENABLED Aug 14 2025 via a REDESIGN: the watch sensor captures raw data but the SpO2 value is now COMPUTED ON THE PAIRED iPhone (shown in the Health app Respiratory section). The sensor capability never changed; the legal/computation pathway did - a clean capability-present-but-regulatory-blocked exemplar.
• Verification posture: Boundary: biometric-primary + AI-augmented (would exist without AI but degraded -> biometric, distinct from form_factor=wearable AI-primary). Clinical-validation posture: SUBSTANTIAL (Apple Heart Study/Stanford NEJM 2019; sleep apnea N=1,448; hypertension >100k participants) - highest peer-review volume of the cohort. NOT verified: final Masimo legal end-state (ongoing); whether redesigned SpO2 matches original accuracy (no published comparison).

specs

Apple Watch (current: Series 11 + Ultra 3, Sept 2025; Series 9/10 + Ultra 2 supported). Sensors: optical (PPG) HR, electrical ECG, temperature, accelerometer/gyro, blood-oxygen. AI/health: ECG app, AFib/irregular-rhythm notifications, AFib History, fall + crash detection, Vitals, sleep-apnea notifications, hypertension notifications. Hardware purchase; NO subscription for the FDA-cleared medical features.

battery

24 h

weight_kg

0.039

formFactor

biometric (biometric-primary smartwatch + AI augmentation; FDA-cleared cardiac/sleep AI)

fda_clearance

{"source":"https://www.fda.gov/medical-devices/recently-approved-devices/apple-watch-series-4-k183742","status":"cleared","details":"FDA-cleared ECG app (K183742, 2018); irregular rhythm notification (K181286, 2018); atrial fibrillation history feature (K223771, 2022). NOT a continuous glucose monitor.","audited_at":"2026-06-07","source_name":"FDA","health_claim":"Heart rhythm detection + ECG recording. Wellness/fitness primary; specific arrhythmia features FDA-cleared.","verification_posture":"verified"}

What's under the hood

No brain on file for Apple Watch.

Frequently asked questions

Is the Apple Watch actually available for purchase?

Yes, shipping now.Source: Apple Watch ECG app + Irregular Rhythm Notification via FDA De Novo (DEN180044/DEN180042, 2018)

What does the Apple Watch cost?

Apple Watch costs $399-$799 one-time (actual sale price).Source: Apple (Apple Watch)

Does the Apple Watch require a subscription?

No. The Apple Watch works fully without a subscription; all health, workout, and smartwatch features are included. Apple Fitness+, Oceanic+, and Apple Music are separate optional subscriptions.Source: Apple pricing page

Does the Apple Watch really detects irregular heart rhythm?

Yes, verified. Apple Watch performs this autonomously.Sources: Apple Watch ECG app and irregular rhythm notification received FDA 510(k) De Novo clearance (December 2018). The Apple Heart Study (Stanford + Apple, 419,000 participants, NEJM 2019) validated detection of atrial fibrillation with 84% PPV. Series 4+ ECG app generates physician-reviewable PDF rhythm strip., Perez et al. NEJM 2019: 'Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation'; Apple Heart Study: 419,297 participants; irregular pulse notification PPV 84% for concurrent AFib on ECG patch; sent notification to <0.5% of participants.

Does the Apple Watch really tracks heart health?

Yes, verified. Apple Watch performs this autonomously.Source: Apple Watch heart health features: continuous resting HR, HRV, cardio fitness (VO2 max estimation), Low/High HR notifications, irregular rhythm notification, FDA-cleared ECG app. VO2 max validated by Apple research study (JMIR 2021).

Does the Apple Watch really tracks blood oxygen (spo2)?

Claimed by Apple; no verified demonstration on file.Source: Apple Blood Oxygen app support page: measures blood oxygen (SpO2) with LED sensors + photodiodes; designed for general fitness/wellness, NOT medical-grade pulse oximetry. Apple removed SpO2 hardware from Apple Watch Series 9 and Ultra 2 sold in the US in December 2023 following Masimo patent infringement ruling (ITC import ban). Feature restored after Apple-Masimo licensing agreement in 2024.

Does the Apple Watch really tracks fitness and activity?

Yes, verified. Apple Watch performs this autonomously.Sources: Apple Watch Series 10 health features: Activity Rings (Move/Exercise/Stand), Workout app with GPS for 90+ sports, automatic workout detection, VO2 max estimation, cycle tracking, crash detection. Activity Rings have been central to Apple Watch since Series 0 (2015); validated step and calorie accuracy in multiple peer-reviewed studies., Shcherbina et al. 2017 (JMIR mHealth): 'Accuracy in Wrist-Worn, Sensor-Based Measurements of Heart Rate and Energy Expenditure in a Diverse Cohort'; Apple Watch showed lowest mean absolute percent error for energy expenditure (27%) among 7 wrist-worn trackers tested -- still high but best in class for calorie estimate.

Does the Apple Watch really tracks sleep?

Claimed by Apple; no verified demonstration on file.Source: Apple Support: Sleep tracking on Apple Watch. Basic sleep tracking added watchOS 8 (2021); sleep stages (Core/Deep/REM/Awake) added watchOS 9 (Series 4+, 2022). Sleep Insights and Sleep History in Health app. Apple does not cite peer-reviewed PSG validation studies for sleep stage accuracy; feature is wellness-grade, not clinical.

Where is the Apple Watch being used?

Apple Watch is in use at: Global.Source: Apple

Is the Apple Watch safe?

Incidents on record: 1 (1 regulatory_action). See Apple disabled Blood Oxygen on US Apple Watch to comply with a Masimo ITC exclusion order.Source: Apple disabled Blood Oxygen on US Apple Watch to comply with a Masimo ITC exclusion order

How does the Apple Watch handle privacy?

Apple has disclosed 13 privacy practices for Apple Watch: data deletion control (HealthKit app permissions never expire on their own. One tap of Allow gives an app unlimited read access to all your health history and f..), cloud upload (Health data in iCloud is only end-to-end encrypted if you turn on Advanced Data Protection, which is off by default. Without it, Apple ho..), third-party sharing (If you joined an Apple Research study, your ongoing body data goes to universities including Harvard and Michigan, and the NIH. Enrollmen..), data retention (You control how long health data is kept and can edit or delete it anytime. Research study data is automatically and permanently deleted..), data sale (Does not sell your health data under any US state privacy law, including California and Nevada), training data use (If you opt into the Improve Health and Activity program, Apple uses your data to improve health features. This data is aggregated and not..), on-device processing (Key health features including Medications, Mental Health, Siri health requests, Cycle Tracking, and Trends run entirely on your device, s..), location tracking (Health features may use your region to check availability. If you opt into the Improve Health and Activity program, Apple also collects y..), biometric storage (Continuously tracks your heart rhythm, wrist temperature, blood oxygen, breathing, and sleep patterns. When synced to iCloud with two-fac..), biometric storage (Apple Watch collects health information relating to physical or mental health status, fitness and exercise details, precise location for..), data sale (Apple does not sell your personal data including as sale is defined in Nevada and California; Apple also does not share your personal dat..), data deletion control (Users can access, delete, correct, transfer, and restrict processing of their personal data via the Apple Data and Privacy page at privac..), and data retention (Apple retains personal data only for as long as necessary to fulfill the purposes for which it was collected, working to retain data for..).Sources: Apple Developer: Protecting User Privacy in HealthKit, New York Times: Period-Tracking Apps and Privacy After Dobbs, June 2022, Apple Support: Advanced Data Protection for iCloud, Apple Transparency Report, Apple Research App overview, https://www.apple.com/legal/privacy/data/en/health-app/, https://www.apple.com/legal/privacy/consumer-health-personal-data/en-ww/, https://www.apple.com/legal/privacy/data/en/improve-health-activity/, maker privacy policy

Who makes the Apple Watch?

Apple Watch is made by Apple, based in Cupertino, California, USA.Source: Apple Watch ECG app + Irregular Rhythm Notification via FDA De Novo (DEN180044/DEN180042, 2018)

What iPhone do I need for Apple Watch?

Apple Watch Ultra 3, Series 11, and SE 3 require iPhone 11 or later with iOS 26 or later.Source: Apple documentation

Can I swim with Apple Watch Series 11 or SE 3?

Apple Watch SE 3 and Series 11 have a water resistance rating of 50 meters under ISO standard 22810:2010, but should not be used for scuba diving, waterskiing, or other high-velocity water activities.Source: Apple documentation

Can I scuba dive with Apple Watch Ultra 3?

Apple Watch Ultra 3 has a water resistance rating of 100 meters and supports recreational scuba diving to 40 meters with the Oceanic+ app, which requires a subscription; it should not be used for diving below 40 meters.Source: Apple documentation

Is water resistance permanent on Apple Watch?

Water resistance is not a permanent condition and can diminish over time.Source: Apple documentation

How long does Apple Watch Ultra 3 battery last?

Ultra 3 battery lasts 42 hours in normal use and 72 hours in Low Power Mode, based on specific usage patterns including time checks, notifications, app use, workouts, and sleep tracking.Source: Apple documentation

Which Apple Watch models have ECG?

The ECG app is available on Apple Watch Series 4 and later, excluding Apple Watch SE models, and is intended for use by people 22 years old or older.Source: Apple documentation

Which Apple Watch models detect sleep apnea?

Sleep apnea detection is available on Apple Watch Series 9 and later, Ultra 2 and later, and SE 3, and is intended to detect signs of moderate to severe sleep apnea for people 18 years old or older without a diagnosis.Source: Apple documentation

Does Apple Watch require a cellular plan?

A data plan is required for cellular features; 5G is available in select markets and through select carriers; some features work without cellular when connected to iPhone via Bluetooth or Wi-Fi.Source: Apple documentation

How long is satellite service included with Apple Watch Ultra 3?

Emergency SOS, Find My, and Messages via satellite are included for free for two years with the activation of Apple Watch Ultra 3; satellite connectivity is provided by Globalstar and its affiliates.Source: Apple documentation

Is Apple Watch dust resistant?

Apple Watch Series 11 and Apple Watch Ultra 3 are rated IP6X dust resistant.Source: Apple documentation

Can Apple Watch Cycle Tracking be used for birth control?

The Cycle Tracking app should not be used for birth control or to diagnose a health condition.Source: Apple documentation

Does Apple Watch require a subscription?

Core health and smartwatch features work without a subscription; Apple Fitness+, Oceanic+ diving app, and Apple Music each require their own separate subscriptions.Source: Apple documentation

Who can use Apple Watch hypertension notifications?

Hypertension notifications are not intended for use by people under 22 years old, those previously diagnosed with hypertension, or pregnant persons.Source: Apple documentation

What colors does Apple Watch Series 11 come in?

Series 11 comes in Space Gray, Silver, Rose Gold, Jet Black, Natural, Gold, and Slate.Source: Apple documentation

Video

Compare side by side

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Sources

1. Apple Watch ECG app + Irregular Rhythm Notification via FDA De Novo (DEN180044/DEN180042, 2018) · https://www.apple.com/newsroom/2018/12/ecg-app-and-irregular-heart-rhythm-notification-available-today-on-apple-watch/ ↗
2. Apple re-enables Blood Oxygen in US (Aug 14 2025; calculation moved to the paired iPhone) · https://www.apple.com/newsroom/2025/08/an-update-on-blood-oxygen-for-apple-watch-in-the-us/ ↗
3. FDA clears Apple Watch sleep-apnea notifications (Sept 2024; mod-severe OSA, 18+, not diagnostic) · https://www.cnbc.com/2024/09/16/fda-clears-apples-sleep-apnea-detection-feature-for-use-heres-how-it-works.html ↗
4. Apple Watch hypertension notifications FDA-cleared (Sept 2025; 30-day passive screening) · https://www.engadget.com/wearables/apple-watch-series-11-receives-fda-clearance-for-hypertension-alerts-120046138.html ↗
5. Apple Watch ECG app De Novo DEN180044 (granted Sep 11 2018; single-lead ECG, AFib vs sinus, OTC) · https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?ID=DEN180044 ↗
6. Apple Watch Sleep Apnea Notification 510(k) K240929 (Sep 13 2024; moderate-to-severe OSA signs, 18+) · https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240929 ↗
7. Apple Watch Hypertension Notification 510(k) K250507 (Sep 11 2025; ~30-day chronic-hypertension notification) · https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250507 ↗
8. Apple Heart Study: large-scale smartwatch AFib identification (Perez et al., NEJM 2019; PMID 31722151) · https://www.nejm.org/doi/full/10.1056/NEJMoa1901183 ↗
9. Apple Watch Series 11 · https://www.apple.com/apple-watch-series-11/specs/ ↗
10. Apple Watch ECG app and irregular rhythm notification received FDA 510(k) De Novo clearance (December 2018). The Apple Heart Study (Stanford + Apple, 419,000 participants, NEJM 2019) validated detection of atrial fibrillation with 84% PPV. Series 4+ ECG app generates physician-reviewable PDF rhythm strip. · https://www.fda.gov/medical-devices/software-as-medical-device-samd/digital-health-center-excellence ↗ · 2019-03-01
11. Apple Watch heart health features: continuous resting HR, HRV, cardio fitness (VO2 max estimation), Low/High HR notifications, irregular rhythm notification, FDA-cleared ECG app. VO2 max validated by Apple research study (JMIR 2021). · https://www.apple.com/apple-watch-series-10/health/ ↗ · 2024-09-01
12. Apple Blood Oxygen app support page: measures blood oxygen (SpO2) with LED sensors + photodiodes; designed for general fitness/wellness, NOT medical-grade pulse oximetry. Apple removed SpO2 hardware from Apple Watch Series 9 and Ultra 2 sold in the US in December 2023 following Masimo patent infringement ruling (ITC import ban). Feature restored after Apple-Masimo licensing agreement in 2024. · https://support.apple.com/en-us/101562 ↗ · 2024-03-01
13. Shcherbina et al. 2017 (JMIR mHealth): 'Accuracy in Wrist-Worn, Sensor-Based Measurements of Heart Rate and Energy Expenditure in a Diverse Cohort'; Apple Watch showed lowest mean absolute percent error for energy expenditure (27%) among 7 wrist-worn trackers tested -- still high but best in class for calorie estimate. · https://pubmed.ncbi.nlm.nih.gov/31166000/ ↗ · 2017-05-01
14. Apple Support: Sleep tracking on Apple Watch. Basic sleep tracking added watchOS 8 (2021); sleep stages (Core/Deep/REM/Awake) added watchOS 9 (Series 4+, 2022). Sleep Insights and Sleep History in Health app. Apple does not cite peer-reviewed PSG validation studies for sleep stage accuracy; feature is wellness-grade, not clinical. · https://support.apple.com/en-us/111851 ↗ · 2022-09-12
15. Apple official YouTube (@Apple), embedded under standard YouTube embed terms. oEmbed author_url verified 2026-06-04. Maker product video. · https://www.youtube.com/watch?v=V3J9nQzrIUk ↗ · 2026-06-04
16. Apple (Apple Watch) · https://www.apple.com/apple-watch-series-11/ ↗ · 2025-09-09
17. Apple · https://www.apple.com/apple-watch/ ↗
18. Apple Watch in Health | Apple · https://www.apple.com/healthcare/apple-watch/ ↗
19. Apple Developer: Protecting User Privacy in HealthKit · https://developer.apple.com/documentation/healthkit/protecting_user_privacy ↗
20. New York Times: Period-Tracking Apps and Privacy After Dobbs, June 2022 · https://www.nytimes.com/2022/06/24/technology/period-apps-privacy-abortion.html ↗
21. Apple Support: Advanced Data Protection for iCloud · https://support.apple.com/en-us/108756 ↗
22. Apple Transparency Report · https://www.apple.com/legal/transparency/ ↗
23. Apple Research App overview · https://www.apple.com/ios/research-app/ ↗
24. https://www.apple.com/legal/privacy/data/en/health-app/ ↗
25. https://www.apple.com/legal/privacy/consumer-health-personal-data/en-ww/ ↗
26. https://www.apple.com/legal/privacy/data/en/improve-health-activity/ ↗
27. maker privacy policy · https://www.apple.com/legal/privacy/en-ww/ ↗ · 2026-06-17