# Apple Watch

Manufacturer: [Apple](/companies/apple)  
Category: biometric

## Summary

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.

## Top line

> Apple Watch is shipping now at $399-$799 (actual sale price), no capability claims are on file, the model has no verified field deployments in the registry, and no incidents are on record.

## Readiness

- **Availability** (shipping-now): Shipping now.
- **Price honesty** (actual-sale-price): One price on file: $399-$799 (actual sale price).
- **Capability honesty** (no-claims): No reviewed capability claims on file for Apple Watch.
- **Real-world use** (commercial): Maturity: commercial. No verified deployments in the registry.
- **Safety record** (no-incidents): No incidents on record. No verified deployments either.

## What it claims to do

_No reviewed capability claims on file._

## Price

- $399-$799, _actual-sale-price_ ([Apple (Apple Watch)](https://www.apple.com/apple-watch-series-11/)) _as of 2025-09-09_

## Real-world use

_No verified deployments on file for Apple Watch._

## Safety record

_No incidents on record. No verified deployments either, so the absence is uninformative._

## Privacy

_No privacy practices disclosed or on file for Apple Watch._

## Specs

- **notes**: [{"label":"FDA clearances (the verification anchor)","value":"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."},{"label":"CAP-FLAG (marketing beyond clearance)","value":"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."},{"label":"Disabled-feature exemplar (verified-vs-claimed)","value":"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."},{"label":"Verification posture","value":"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.
- **formFactor**: biometric (biometric-primary smartwatch + AI augmentation; FDA-cleared cardiac/sleep AI)

## 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)](https://www.apple.com/newsroom/2018/12/ecg-app-and-irregular-heart-rhythm-notification-available-today-on-apple-watch/)._

### What does the Apple Watch cost?

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

_Source: [Apple (Apple Watch)](https://www.apple.com/apple-watch-series-11/)._

### Where is the Apple Watch being used?

No verified field deployments on record.

### Is the Apple Watch safe?

No incidents on record, but with no verified field deployments either, the absence is uninformative.

### How does the Apple Watch handle privacy?

No privacy practices disclosed or on file for Apple Watch.

### 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)](https://www.apple.com/newsroom/2018/12/ecg-app-and-irregular-heart-rhythm-notification-available-today-on-apple-watch/)._

## Manufacturer

- [Apple (https://www.apple.com/newsroom/2018/12/ecg-app-and-irregular-heart-rhythm-notification-available-today-on-apple-watch/)](https://www.apple.com/newsroom/2018/12/ecg-app-and-irregular-heart-rhythm-notification-available-today-on-apple-watch/)

## Compared to

- [Ultrahuman Ring (Air / Pro)](/consumer/models/ultrahuman-ring-air)
- [Stelo](/consumer/models/stelo)
- [Withings ScanWatch](/consumer/models/withings-scanwatch)

## 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 (Apple Watch)](https://www.apple.com/apple-watch-series-11/) · 2025-09-09

_Canonical: https://deploy.report/models/apple-watch_