510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K230457Substantially Equivalent

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

EMPATICA S.r.l., Milan, IT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K230457 is the FDA 510(k) clearance record for Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal, a class II device, cleared for Empatica S.r.l. on under FDA product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)). FDA records list 9 510(k) clearances for Empatica S.r.l., from to . As of , FDA records show no recalls naming K230457.

Clearance record

Decision date
Received
(251 days to decision)
Product code
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Regulation
21 CFR 870.2300
Device class
Class II
Review panel
Cardiovascular
Applicant
Empatica S.r.l. Via Stendhal, 36, Milan, IT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MWI

Trailing 12 months
5 clearances under product code MWI in the twelve months to October 2026, August 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code MWI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20261
May 20260
June 20261
July 20260
August 20262
September 20260
October 20260