Empatica S.r.l.: FDA clearances and approvals
Empatica S.r.l. has 9 FDA 510(k) clearances (first 2018, latest 2026), across 5 product codes in 3 review panels. Median 510(k) review time: 161 days. Since 2017 its median was 161 days, against 207 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 2 | 142 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 201 |
| 2023 | 1 | 251 |
| 2024 | 1 | 149 |
| 2025 | 3 | 118 |
| 2026 | 1 | 190 |
Review time against the same product codes
Since 2017, Empatica S.r.l.'s cleared 510(k)s took a median 161 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 207 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| POS | Physiological Signal Based Seizure Monitoring System | 4 | 4 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 2 | 2 |
| DQA | Oximeter | 1 | 1 |
| GYD | Transducer, Tremor | 1 | 1 |
| LEL | Device, Sleep Assessment | 1 | 1 |
Review panels
- Neurology (6)
- Cardiovascular (2)
- Anesthesiology (1)
Most recent Empatica S.r.l. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260374 | Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal | GYD | 2026-08-14 | 190 |
| K252981 | EmbraceMini | LEL | 2025-12-22 | 96 |
| K250515 | EpiMonitor | POS | 2025-06-19 | 118 |
| K242737 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | MWI | 2025-06-06 | 268 |
| K232915 | EpiMonitor | POS | 2024-02-15 | 149 |
| K230457 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | MWI | 2023-10-30 | 251 |
| K221282 | Empatica Health Monitoring Platform | DQA | 2022-11-20 | 201 |
| K181861 | Embrace | POS | 2018-12-20 | 161 |
| K172935 | Embrace | POS | 2018-01-26 | 122 |
Recalls
openFDA lists no recalls under a recalling firm named Empatica S.r.l..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Empatica S.r.l. have?
Empatica S.r.l. has 9 FDA 510(k) clearances (first 2018, latest 2026), across 5 product codes in 3 review panels.
How long does FDA take to clear Empatica S.r.l.'s 510(k)s?
The median time from FDA receipt to decision across Empatica S.r.l.'s cleared 510(k)s is 161 days. Since 2017: 161 days, versus 207 days for all cleared 510(k)s in the same product codes.
What devices does Empatica S.r.l. make?
Its most frequent FDA product codes are POS (Physiological Signal Based Seizure Monitoring System, 4); MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), 2); DQA (Oximeter, 1).
Has Empatica S.r.l. had device recalls?
openFDA lists no recalls under a recalling firm name matching Empatica S.r.l. Related entities may recall under other names.
Next steps
- See all 9 Empatica S.r.l. clearances with predicates and recalls
- Run predicate analysis for product code POS, Empatica S.r.l.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.