Company ยท IT
Empatica S.r.l.
FDA 510(k) clearances and medical device recalls filed under this name, 2018 to 2026. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (2 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 14, 2026 | K260374 | Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Mon Empatica S.r.l., IT | GYD |
| Dec 22, 2025 | K252981 | EmbraceMini Empatica S.r.l., IT | LEL |
| Jun 19, 2025 | K250515 | EpiMonitor Empatica S.r.l., IT | POS |
| Jun 6, 2025 | K242737 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal Empatica S.r.l., IT | MWI |
| Feb 15, 2024 | K232915 | EpiMonitor Empatica S.r.l., IT | POS |
| Oct 30, 2023 | K230457 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal Empatica S.r.l., IT | MWI |
| Nov 20, 2022 | K221282 | Empatica Health Monitoring Platform Empatica S.r.l., IT | DQA |
| Dec 20, 2018 | K181861 | Embrace Empatica S.r.l., IT | POS |
| Jan 26, 2018 | K172935 | Embrace Empatica S.r.l., IT | POS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||