Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Empatica S.r.l. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
161 daysmedian FDA review time
268 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252981 | EmbraceMini | Empatica S.r.l. | 2025-12-22 | 96 | 0 |
| K250515 | EpiMonitor | Empatica S.r.l. | 2025-06-19 | 118 | 0 |
| K242737 | Empatica Health Monitoring Platform; EmbracePlus; Empatica C | Empatica S.r.l. | 2025-06-06 | 268 | 0 |
| K232915 | EpiMonitor | Empatica S.r.l. | 2024-02-15 | 149 | 0 |
| K230457 | Empatica Health Monitoring Platform; EmbracePlus; Empatica C | Empatica S.r.l. | 2023-10-30 | 251 | 0 |
| K221282 | Empatica Health Monitoring Platform | Empatica S.r.l. | 2022-11-20 | 201 | 0 |
| K181861 | Embrace | Empatica S.r.l. | 2018-12-20 | 161 | 1 |
| K172935 | Embrace | Empatica S.r.l. | 2018-01-26 | 122 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda