Is Apple Watch Sleep Apnea Notifications FDA approved or cleared?
Yes. Apple Watch Sleep Apnea Notifications by Apple, Inc. is named in the FDA register with a 510(k) clearance, latest decision in 2024.
At a glance
| Product | Apple Watch Sleep Apnea Notifications |
|---|---|
| Maker | Apple, Inc. |
| Care area | Sleep & breathing |
| What it does | Apple Watch feature that uses breathing disturbances measured overnight to notify users of signs of possible moderate to severe sleep apnea |
| FDA | 510(k), latest decision 2024 |
| Verification level | Exact product named in the FDA record (checked 18 October 2026) |
| EU (CE) | No CE listing found |
| Website | apple.com/apple-watch-series-11 |
| Status | FDA verified |
| Last checked | 18 October 2026 |
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Certified Health Apps Pro gives you the FDA reference number, decision date and a direct link to the official record, plus the EU certificate and notified body, for every app. See Pro · Free guide: how to check a health app in two minutes
Certified Health Apps Pro gives you the FDA reference number, decision date and a direct link to the official record, plus the EU certificate and notified body, for every app. See Pro · Free guide: how to check a health app in two minutes
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