Is Owlet Dream Sock FDA approved or cleared?
Yes. Owlet Dream Sock by Owlet Baby Care, Inc. is named in the FDA register with a De Novo authorisation, latest decision in 2023.
In the EU: CE class IIb, found in EUDAMED. The manufacturer holds a valid notified body certificate under the MDR in EUDAMED.
At a glance
| Product | Owlet Dream Sock |
|---|---|
| Maker | Owlet Baby Care, Inc. |
| Care area | Vital signs & remote monitoring |
| What it does | Smart sock that tracks a baby's pulse rate and oxygen level with alerts to parents |
| FDA | De Novo, latest decision 2023 |
| Verification level | Exact product named in the FDA record (checked 18 October 2026) |
| EU (CE) | Class IIb |
| EU certificate | Manufacturer certificate from a notified body (MDR) in EUDAMED (checked 18 October 2026) |
| Website | owletcare.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