# Empatica S.r.l.

- Location (FDA's records): Milan, IT
- FDA decisions: 9 (2018–2026): 9 510(k) clearances
- Product codes: POS (4), MWI (2), DQA (1), LEL (1), GYD (1)
- 510(k) review time since 2016: median 196 days, against 219 for FDA's reviews in the same codes and years (2 of 6 faster)
- Predicates its devices cite: 16 (9 its own); citations of its devices by later devices: 13 (9 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Current Health, Ltd.: 2 (https://510kreport.com/company/current-health)
- Spry Health, Inc.: 2 (https://510kreport.com/company/spry-health)
- Actigraph, LLC: 1 (https://510kreport.com/company/actigraph)
- Lgch, Inc.: 1 (https://510kreport.com/company/lgch)
- Gkc Manufacturing Pty, Ltd.: 1 (https://510kreport.com/company/gkc-manufacturing)

## Firms that cite its devices most
- Neuro Event Labs OY: 1 (https://510kreport.com/company/neuro-event-labs)
- Epiwatch, Inc.: 1 (https://510kreport.com/company/epiwatch)
- Happy Health, Inc.: 1 (https://510kreport.com/company/happy-health)
- Livassured BV: 1 (https://510kreport.com/company/livassured)

## Its most-cited devices
- K230457: Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal (2023), cited by 4
- K181861: Embrace (2018), cited by 4
- K221282: Empatica Health Monitoring Platform (2022), cited by 2
- K252981: EmbraceMini (2025), cited by 1
- K232915: EpiMonitor (2024), cited by 1
- K172935: Embrace (2018), cited by 1

## Recent decisions
- K260374: Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal (Aug 14, 2026)
- K252981: EmbraceMini (Dec 22, 2025)
- K250515: EpiMonitor (Jun 19, 2025)
- K242737: Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal (Jun 6, 2025)
- K232915: EpiMonitor (Feb 15, 2024)
- K230457: Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal (Oct 30, 2023)
- K221282: Empatica Health Monitoring Platform (Nov 20, 2022)
- K181861: Embrace (Dec 20, 2018)

Source page: https://510kreport.com/company/empatica