EmbraceMini
FDA 510(k) K252981 · Empatica S.r.l.
510(k) numberK252981
Submission
- Device name
- EmbraceMini
- Applicant
- Empatica S.r.l.
Milan, IT - Received
- September 17, 2025
- Decision date
- December 22, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Cadwell Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260374 | Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…GYD · Traditional | 08/14/2026SE |
| K250515 | EpiMonitorPOS · Special | 06/19/2025SE |
| K242737 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalMWI · Traditional | 06/06/2025SE |
| K232915 | EpiMonitorPOS · Traditional | 02/15/2024SE |
| K230457 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalMWI · Traditional | 10/30/2023SE |
| K221282 | Empatica Health Monitoring PlatformDQA · Traditional | 11/20/2022SE |
| K181861 | EmbracePOS · Traditional | 12/20/2018SE |
| K172935 | EmbracePOS · Traditional | 01/26/2018SE |
Questions and answers
When was EmbraceMini cleared by the FDA?
EmbraceMini (K252981) received a 510(k) decision of Substantially Equivalent on December 22, 2025, 96 days after the submission was received.
What is the product code of K252981?
The FDA product code is LEL – Device, Sleep Assessment, a Class II (moderate risk) device regulated under 21 CFR 882.5050.