510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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EMPATICA S.r.l.

Milano Milano, IT

EMPATICA S.r.l. appears in FDA device records in Milano Milano, IT. FDA records list 9 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
9
PMA records
0
Recall records
1
Registered establishments
2

510(k) clearance history

FDA records hold 9 510(k) clearances for EMPATICA S.r.l. between 2018 and 2026. The busiest year on record is 2025, with 3. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for EMPATICA S.r.l., by decision year
YearClearances
20182
20221
20231
20241
20253
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care PortalGYDSubstantially Equivalent
K252981EmbraceMiniLELSubstantially Equivalent
K250515EpiMonitorPOSSubstantially Equivalent
K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalMWISubstantially Equivalent
K232915EpiMonitorPOSSubstantially Equivalent
K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalMWISubstantially Equivalent
K221282Empatica Health Monitoring PlatformDQASubstantially Equivalent
K181861EmbracePOSSubstantially Equivalent
K172935EmbracePOSSubstantially Equivalent

Registered establishments

FDA registered establishments for EMPATICA S.r.l., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30129339693012933969EMPATICA S.r.l.Via Enrico Stendhal 36, Milano 20144 IT2026and 1 more, listed in full below
30149775783014977578EMPATICA, Inc.14TH FLOOR, 1 BROADWAY, Cambridge, MA 02142 US2026No device listings on this registration

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0159-2024Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities during periods of rest. Models: (1) Flamingo Pink EM2-FP-S; (2) Sky Blue EM2-SB-2; (3) Seoul Grey EM2-SG-S; (4) Boston Blue EM2-BB-S; (5) Milan Black EM2-MB-SMay have a battery life lasting less than the full 48 hours, requiring the device to be charged more frequently.Class IIOpen, Classified

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Data as of , FDA export datePage updated Source: openFDA, public domain