510(k) Report

FDA applicant

Empatica S.r.l.

Milan, IT9 decisions2018–20261 recall

FDA records 9 decisions for Empatica S.r.l. (Milan, IT) from 2018 to 2026: 9 510(k) clearances. Most are in product codes POS (Physiological Signal Based Seizure Monitoring…) and MWI (Monitor, Physiological, Patient (Without…). Since 2016 its 510(k)s took a median of 196 days from receipt to decision, against 219 for FDA’s reviews in the same codes and years. Its devices cite 16 predicates, 9 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Empatica S.r.l.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2025

2018: 22022: 12023: 12024: 12025: 32026 (partial year): 1
2018high 3 (2025) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

1in 2023

2023: 1
2018high 1 (2023) · low 0 (2018)2026

Class I Class II/III not classified

FIG. 1 — Empatica S.r.l. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • POSPhysiological Signal Based Seizure Monitoring System4decisions
  • MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)2decisions
  • DQAOximeter1decision
  • LELDevice, Sleep Assessment1decision
  • GYDTransducer, Tremor1decision

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 196 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 219 days; 2 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 16 predicates; 9 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 13 times; 9 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l. · 20234cite it
  • K181861EmbraceEmpatica S.r.l. · 20184cite it
  • K221282Empatica Health Monitoring PlatformEmpatica S.r.l. · 20222cite it
  • K252981EmbraceMiniEmpatica S.r.l. · 20251cites it
  • K232915EpiMonitorEmpatica S.r.l. · 20241cites it
  • K172935EmbraceEmpatica S.r.l. · 20181cites it

What has FDA decided for it lately?

  • K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica…Empatica S.r.l. · 2026
  • K252981EmbraceMiniEmpatica S.r.l. · 2025
  • K250515EpiMonitorEmpatica S.r.l. · 2025
  • K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l. · 2025
  • K232915EpiMonitorEmpatica S.r.l. · 2024
  • K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l. · 2023
  • K221282Empatica Health Monitoring PlatformEmpatica S.r.l. · 2022
  • K181861EmbraceEmpatica S.r.l. · 20181 recall

All 9 as Empatica S.r.l. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K181861Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children…Jul 13, 2023Class II