# K221282: Empatica Health Monitoring Platform

- Pathway: 510(k) (Traditional)
- Applicant: Empatica S.r.l.
- Decided: Nov 20, 2022 after 201 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 38 generations back to K941811 (1994). 411 ancestors in all.
7 later devices descend from it; 2 cite it directly.
2 of 419 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181352: Loop System, Spry Health, Inc. (2019) Summary page 5.
- K191272: Wearable Device, Wearable Package, Current Health, Ltd. (2019) Summary page 5.
- K181077: ActiGraph CentrePoint Insight Watch, Actigraph (2018) Summary page 5.
- (no number) Empatica E4: named in the summary without a submission number

## Most influential descendants
- K230457: Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal (2023), 4 descendants of its own
- K252981: EmbraceMini (2025), 1 descendant of its own
- K232915: EpiMonitor (2024), 1 descendant of its own
- 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
- K250515: EpiMonitor (2025), 0 descendants of its own

## Indications for use
The Empatica Health Monitoring Platform is a wearable device and paired mobile and cloud-based software platform intended to be used by trained healthcare professionals or researchers to remotely monitor physiologic parameters in ambulatory individuals 18 years of age and older in home-healthcare environments. The device supports continuous data collection for monitoring the following physiological parameters: • Peripheral skin temperature, • Electrodermal activity, • Blood Oxygen Saturation under no motion conditions, • Activity associated with movement during sleep. The Empatica Health Monitoring Platform can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable. The Empatica Health Monitoring Platform is not intended for SpO2 monitoring in conditions of motion or low perfusion. The Empatica Health Monitoring Platform is intended for peripheral skin temperature monitoring, where monitoring temperature at the wrist is clinically indicated.

Source page: https://510kreport.com/device/K221282
Methodology: https://510kreport.com/methodology