Is Samsung Sleep Apnea Feature FDA approved or cleared?
Yes. Samsung Sleep Apnea Feature by Samsung Electronics Co., Ltd. is named in the FDA register with a De Novo authorisation, first authorised in 2024, latest decision in 2026.
In the EU: CE class IIa, found in EUDAMED. The manufacturer holds a valid notified body certificate under the MDR in EUDAMED.
At a glance
| Product | Samsung Sleep Apnea Feature |
|---|---|
| Maker | Samsung Electronics Co., Ltd. |
| Care area | Sleep & breathing |
| What it does | Galaxy Watch feature that detects signs of moderate to severe obstructive sleep apnea |
| FDA | De Novo, latest decision 2026 |
| Verification level | Exact product named in the FDA record (checked 18 October 2026) |
| EU (CE) | Class IIa |
| EU certificate | Manufacturer certificate from a notified body (MDR) in EUDAMED (checked 18 October 2026) |
| Website | samsung.com |
| Status | FDA verified |
| Last checked | 7 October 2026 |
Need the evidence behind this entry?
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
Other apps in Sleep & breathing
- AcuPebble™ Ox100
- Aevice Wheeze Detection Module
- AeviceMD
- AireHealth Nebulizer
- ANNE Sleep
- Apple Watch Sleep Apnea Notifications
- Belun Ring
- CapMedic