DEPLOYDatabase

Company

Apple

apple.com

Consumer-electronics company (Cupertino CA; NASDAQ: AAPL) whose Apple Watch is a biometric-primary smartwatch with FDA-cleared cardiac/sleep AI (ECG, AFib,…

Track Apple
Founded
1976
HQ
Cupertino, California, USA
Status
public (NASDAQ: AAPL)

The verified answer

As of Aug 2026, DEPLOY verifies Apple: 1 model, 1 deployment across 1 region, 1 active incident. 4 sources back the record.

Regulatory status2 FDA 510(k) clearances2 FDA De Novo authorizations1 ITC exclusion order

Apple holds 2 FDA 510(k) clearances and 2 FDA De Novo authorizations and has 1 ITC exclusion order on record, per the DEPLOY registry.

See all 5 filings
PublicNASDAQ: AAPL

CategoryBiometric wearables

Models

1

Deployments

1

Overview

Consumer-electronics company (Cupertino CA; NASDAQ: AAPL) whose Apple Watch is a biometric-primary smartwatch with FDA-cleared cardiac/sleep AI (ECG, AFib, sleep apnea, hypertension notifications).

Verified record

Verified deployments
1 deployment on file
Active incidents
1 incident on file

Key facts

Product

Apple Watch (Series 11 / Ultra 3); ECG + AFib + sleep apnea + hypertension notifications (FDA-cleared).

Exemplar

SpO2 disabled US (Masimo, Jan 2024) -> re-enabled Aug 2025 via redesign (computed on iPhone).

wikipedia

en.wikipedia.org

wikidata

wikidata.org

Data & sources

News coverage

1

Web sources

3

4 sources backing this record.View all →

Models (1)

View all models →

Current platform

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.

biometricView model →

Partnerships

Every company Apple has built with, alongside the ones only announced in a press release.

7 total4 operating3 just announced1 ended

Most-frequent partners

  1. 1Anki1× joint1 total
  2. 2Broadcom1× joint3 total
  3. 3Corning1× joint4 total
  4. 4Ford Motor Company1× joint1 total
  5. 5Rootline Robotics1× joint1 total
  6. 6SK Hynix1× joint2 total

Most recent

  1. Anki x Apple (iOS Platform)2013-06-10
    with Ankioperating

Apple on the deployment map

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1 verified deployment across 1 region, newest verified Jun 2024. Explore where Apple's robots are operating, by place and type.

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View the full Apple deployment record →

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Relationships

RRootline RoboticsCo-developerFFord Motor CompanyCo-developerTThe Swatch GroupCustomerCCorningCustomerBBroadcomManufacturerSSK HynixCustomerAAnkiTechnology partnerAAppleCustomer

Current leadership (4)

Founders (3)

See all founders across the registry →

Former / Previously (3)

  • Nancy Sun Engineer, Autonomous Vehiclessecondary-verified
  • Garrett Bastable Product operations (Apple Watch launch)secondary-verified
  • Jaime Waydo Chief engineer, autonomous systemssecondary-verified

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.

Full safety record: incidents, sourcing, and exposure data →

Incidents affecting Apple (1)

Includes incidents linked directly to this company, to its models, or to deployments of its models or under its operation. Retracted incidents are excluded from this view but remain reachable at their canonical URLs.

Apple on the data-center map

Every verified data center Apple operates that has a mapped coordinate (7 total). Filled circles are Tier-2 facilities and Tier-1 campuses under this operator; click any pin to open its record.

Apple data centers (7)

AI data centers Apple operates or is a party to, from the DEPLOY data center registry.

Operator customers (1)

Recent coverage

Apple in third-party press

Apple is testing Chinese memory chips for iPhones and MacBooks

Aug 28, 2026

Apple One and Apple TV subscription prices increase by up to 20 percent

Aug 28, 2026

The iPhone Fold could make concerts even worse

Aug 28, 2026

Peer companies

Appears in DEPLOY reports