# K242737: Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal

- Pathway: 510(k) (Traditional)
- Applicant: Empatica S.r.l.
- Decided: Jun 6, 2025 after 268 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- 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.
No later device cites it as a predicate yet.
2 of 415 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.

## 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 for retrospective remote monitoring of physiologic parameters in ambulatory individuals 18 years of age and older in home-healthcare environments. As the platform does not provide real-time alerts related to variation of physiologic parameters, users should use professional judgment in assessing patient clinical stability and the appropriateness of using a monitoring platform designed for retrospective review. The device is intended for continuous data collection supporting intermittent retrospective review of the following physiological parameters: * Pulse Rate, * Blood Oxygen Saturation under no-motion conditions, * Respiratory Rate under no motion conditions, * Peripheral Skin Temperature, * Electrodermal Activity, * 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. The Empatica Health Monitoring Platform is not intended for Respiratory Rate monitoring in motion conditions. This device does not detect apnea and should not be used for detecting or monitoring cessation of breathing. The Empatica Health Monitoring Platform is not intended for Pulse Rate monitoring in patients with chronic cardiac arrhythmias, including atrial fibrillation and atrial/ventricular bigeminy and trigeminy, and is not intended to diagnose or analyze cardiac arrhythmias. The Empatica Health Monitoring Platform is not a substitute for an ECG monitor, and should not be used as the sole basis for clinical decision-making.

Source page: https://510kreport.com/device/K242737
Methodology: https://510kreport.com/methodology