{"id":"7af0d52f-fb71-4b04-88e9-413ec552cb52","companyId":"9d5d53e7-65ec-4e6c-80e0-86c94bff0f48","modelName":"Apple Watch","slug":"apple-watch","description":"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.","formFactor":"biometric","maturityStage":"commercial","lifecycleState":"active","supersededByModelId":null,"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)"},"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://www.apple.com/newsroom/2018/12/ecg-app-and-irregular-heart-rhythm-notification-available-today-on-apple-watch/","title":"Apple Watch ECG app + Irregular Rhythm Notification via FDA De Novo (DEN180044/DEN180042, 2018)","sourceName":"Apple (newsroom)"},{"url":"https://www.apple.com/newsroom/2025/08/an-update-on-blood-oxygen-for-apple-watch-in-the-us/","title":"Apple re-enables Blood Oxygen in US (Aug 14 2025; calculation moved to the paired iPhone)","sourceName":"Apple (newsroom)"},{"url":"https://www.cnbc.com/2024/09/16/fda-clears-apples-sleep-apnea-detection-feature-for-use-heres-how-it-works.html","title":"FDA clears Apple Watch sleep-apnea notifications (Sept 2024; mod-severe OSA, 18+, not diagnostic)","sourceName":"CNBC"},{"url":"https://www.engadget.com/wearables/apple-watch-series-11-receives-fda-clearance-for-hypertension-alerts-120046138.html","title":"Apple Watch hypertension notifications FDA-cleared (Sept 2025; 30-day passive screening)","sourceName":"Engadget"}],"aliases":["Apple Watch","Apple Watch Series 11","Apple Watch Ultra 3"],"collisionRisk":"low","reviewNote":null,"manufacturerTermForTeleop":null,"createdAt":"2026-06-03T22:30:55.943Z","updatedAt":"2026-06-03T22:30:55.943Z","jsonLd":{"@context":"https://schema.org","@type":"Product","@id":"https://registry.deploy.report/models/apple-watch","url":"https://registry.deploy.report/models/apple-watch","name":"Apple Watch","alternateName":["Apple Watch","Apple Watch Series 11","Apple Watch Ultra 3"],"description":"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.","identifier":"7af0d52f-fb71-4b04-88e9-413ec552cb52","category":"biometric","publisher":{"@id":"https://deploy.report/#organization"}}}