Cleared Traditional

Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal

K242737 · Empatica S.R.L. · Cardiovascular

Jun 2025

Decision

268d

Days

Class 2

Risk

About This 510(k) Submission

K242737 is an FDA 510(k) clearance for the Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal, a Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MWI), submitted by Empatica S.R.L. (Milan, IT). The FDA issued a Cleared decision on June 6, 2025, 268 days after receiving the submission on September 11, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K242737 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 11, 2024
Decision Date	June 06, 2025
Days to Decision	268 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	MWI — Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.2300