# K252981: EmbraceMini

- Pathway: 510(k) (Traditional)
- Applicant: Empatica S.r.l.
- Decided: Dec 22, 2025 after 96 days
- Product code: LEL (Device, Sleep Assessment)
- Device class: 2
- Regulation: 21 CFR 882.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 40 generations back to K941811 (1994). 414 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 416 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230457: Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal, Empatica S.r.l. (2023) Summary page 6.

## Most influential descendants
- K260374: Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal (2026), 0 descendants of its own

## Indications for use
EmbraceMini is a wearable device intended to be used by trained healthcare professionals or researchers to remotely monitor limb or body movements in ambulatory individuals in home-healthcare environments and professional healthcare environments. The device supports continuous data collection for monitoring the following physiological parameters: ● Physical movement associated with applications in physiological monitoring ● Activity associated with movement during sleep EmbraceMini can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.

Source page: https://510kreport.com/device/K252981
Methodology: https://510kreport.com/methodology