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Robot model

Apple Watch

Apple Watch (made by Apple Inc., Cupertino; current models the Series 11 and Ultra 3 from September 2025) is a biometric-primary smartwatch with FDA-cleared…

Manufacturer
Apple
Form factor
biometric
Maturity
commercial
Lifecycle
active
Deployments
1

Overview

Apple Watch (made by Apple Inc., Cupertino; current models the Series 11 and Ultra 3 from September 2025) is a biometric-primary smartwatch with FDA-cleared cardiac and sleep AI augmentation, sitting in the new biometric form factor distinct from the AI-primary wearable cohort because it would exist as a watch and biometric tracker without its AI layer, only degraded. Its FDA clearances are the verification anchor: the ECG app and Irregular Rhythm Notification were cleared via FDA De Novo in November 2018, AFib History via a 510(k) in June 2022 but only for users 22 and older already diagnosed with atrial fibrillation, sleep-apnea notifications via a 510(k) in September 2024 for moderate-to-severe obstructive sleep apnea in adults without an existing diagnosis and explicitly not for diagnosis, and hypertension notifications cleared in September 2025 as a 30-day passive screening tool rather than blood-pressure measurement. Marketing that frames AFib History as detecting new atrial fibrillation, or the sleep-apnea and hypertension features as diagnostic or as blood-pressure monitoring, exceeds the cleared indications and is cap-flagged. The blood-oxygen feature is a load-bearing verified-versus-claimed exemplar: it was disabled on US units from January 17, 2024 after the Masimo International Trade Commission import ban, then re-enabled on August 14, 2025 through a redesign in which the watch sensor captures raw data but the oxygen value is computed on the paired iPhone and shown in the Health app, so the sensor capability never changed while the legal and computation pathway did. Apple's clinical-validation posture is substantial, the highest peer-review volume in the cohort, anchored by the Stanford Apple Heart Study and large FDA submission studies, while the final Masimo legal end-state and whether the redesigned blood-oxygen reading matches the original accuracy are not verified.

Verified vs. claimed

Maturity stage
commercial(Commercially deployed with revenue-generating operations.)
Verified deployments
1 deployment on file
Sources on file
9 sources, view all

Key facts

Form factor

biometric-primary smartwatch with AI augmentation

FDA clearances

ECG app + Irregular Rhythm Notification (De Novo Nov 2018), AFib History (510(k) Jun 2022), Sleep Apnea Notifications (510(k) Sept 2024), Hypertension Notifications (Sept 2025)

Sensor suite

optical (PPG) HR, electrical ECG, temperature, accelerometer/gyro, blood-oxygen

Blood oxygen status

disabled on US units Jan 17 2024, re-enabled Aug 14 2025 via redesign computing SpO2 on paired iPhone

Subscription model

hardware purchase; no subscription for FDA-cleared medical features

Price

Apple Watch Series 10 from $399; Ultra 2 $799; SE from $249 (one-time purchase, no subscription)

Pricing model

One-time hardware purchase (no subscription for core features)

Availability

Commercial — Apple Store, Amazon, carriers

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

Form Factor

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

Fda clearance

Source: fda.gov 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

Data & sources

Press releases

1

News coverage

1

Government records

3

Research

1

Web sources

3

9 sources backing this record.View all →

Availability and pricing

Availability
Shipping now
Price
$399 to $799 (actual sale price)as of 2025-09-09
Units in field
Not disclosed
Sales model
Not disclosed
Lead time
Not disclosed

Pricing

One-time purchase

$399 - $799 USDactual sale priceas of 2025-09-09

Source: Apple (Apple Watch)

Price status: actual-sale-price = real published price at time of sale; manufacturer-target = vendor target, not yet realized; analyst-estimate = third-party projection, not a vendor figure; not-announced = no price on record.

Prices verified as of Sep 9, 2025

Deployments (1)

Apple Watch on the deployment map

Where Apple Watch is verified operating. Explore the deployment map by place and type.

Recent activity

Every change to this record is dated, sourced, and independently verified where marked.

Full change history →

Deployment-verified media (2)

PRIMARY SOURCE
Courtesy of Apple

Apple's official how-to for Crash Detection on iPhone and Apple Watch. Crash Detection is a safety-sensor feature; it is distinct from Apple Watch's FDA-cleared health features (ECG, AFib history) and from its wellness metrics (activity rings, sleep stages), which are not medical-grade.

From deployment: Global

PRIMARY SOURCE
Courtesy of Apple

Apple's overview of health tracking with iPhone and Apple Watch. The ECG app and AFib History are FDA-cleared features; sleep and other metrics are wellness-grade.

From deployment: Global

Regulatory filings (5)

Safety record

1 incident on record (1 serious). Most recent: Jan 2024.

serious
1

Most recent: Jan 2024

Only active incidents are counted. Retracted incidents are excluded from this summary but remain reachable at their canonical URLs.

Incidents affecting Apple Watch (1)

Includes incidents linked directly to this model or to deployments of it. Retracted incidents are excluded from this view but remain reachable at their canonical URLs.

Sources (9)

  1. https://www.apple.com/newsroom/2018/12/ecg-app-and-irregular-heart-rhythm-notification-available-today-on-apple-watch/
  2. https://www.apple.com/newsroom/2025/08/an-update-on-blood-oxygen-for-apple-watch-in-the-us/
  3. https://www.cnbc.com/2024/09/16/fda-clears-apples-sleep-apnea-detection-feature-for-use-heres-how-it-works.html
  4. https://www.engadget.com/wearables/apple-watch-series-11-receives-fda-clearance-for-hypertension-alerts-120046138.html
  5. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?ID=DEN180044
  6. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240929
  7. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250507
  8. https://www.nejm.org/doi/full/10.1056/NEJMoa1901183
  9. https://www.apple.com/apple-watch-series-11/specs/

Compare Apple Watch

Common questions

What is Apple Watch?
Apple Watch (made by Apple Inc., Cupertino; current models the Series 11 and Ultra 3 from September 2025) is a biometric-primary smartwatch with FDA-cleared cardiac and sleep AI augmentation, sitting in the new biometric form factor distinct from the AI-primary wearable cohort because it would exist as a watch and biometric tracker without its AI layer, only degraded. Its FDA clearances are the verification anchor: the ECG app and Irregular Rhythm Notification were cleared via FDA De Novo in November 2018, AFib History via a 510(k) in June 2022 but only for users 22 and older already diagnosed with atrial fibrillation, sleep-apnea notifications via a 510(k) in September 2024 for moderate-to-severe obstructive sleep apnea in adults without an existing diagnosis and explicitly not for diagnosis, and hypertension notifications cleared in September 2025 as a 30-day passive screening tool rather than blood-pressure measurement. Marketing that frames AFib History as detecting new atrial fibrillation, or the sleep-apnea and hypertension features as diagnostic or as blood-pressure monitoring, exceeds the cleared indications and is cap-flagged. The blood-oxygen feature is a load-bearing verified-versus-claimed exemplar: it was disabled on US units from January 17, 2024 after the Masimo International Trade Commission import ban, then re-enabled on August 14, 2025 through a redesign in which the watch sensor captures raw data but the oxygen value is computed on the paired iPhone and shown in the Health app, so the sensor capability never changed while the legal and computation pathway did. Apple's clinical-validation posture is substantial, the highest peer-review volume in the cohort, anchored by the Stanford Apple Heart Study and large FDA submission studies, while the final Masimo legal end-state and whether the redesigned blood-oxygen reading matches the original accuracy are not verified.
How much does Apple Watch cost?
Apple Watch is listed at $399 to $799 on the DEPLOY registry. This is an actual sale price on record.
Is Apple Watch actually deployed in the real world?
Yes. Apple Watch is independently verified in real-world operation on the DEPLOY registry, confirmed at named deployment sites with primary sources: not a concept, render, or demo-only.
Is Apple Watch autonomous or teleoperated?
Partly. DEPLOY verifies Apple Watch operating autonomously for Tracks heart health, Detects irregular heart rhythm, and Tracks fitness and activity. Other capabilities (Tracks sleep and Tracks blood oxygen (SpO2)) are only demonstrated under teleoperation or remain vendor claims, not independently verified as autonomous.
What are the specs of Apple Watch?
Apple Watch's recorded specifications on the DEPLOY registry: Battery: 24 h; Weight: 0.039 kg. See the Specs section for the full sourced set.
Methodology: Verified · 9 sources (5 primary) · last reviewed 2026-07-15

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-07-15

Maturity + lifecycle

Maturity stage: commercial

Lifecycle: active

Architectural position

Cohort: biometric

Sources by quality tier

3
unclassified
Unclassified source
3
primary-fda-database
FDA database
1
secondary-established-publication
Established publication
1
primary-academic-peer-reviewed
Peer-reviewed clinical / academic
1
primary-company-ir
Company IR disclosure

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for Apple Watch.

Recent coverage

Apple Watch in third-party press