510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K252981Substantially Equivalent

EmbraceMini

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

K252981 is the FDA 510(k) clearance record for EmbraceMini, a class II device, cleared for Empatica S.r.l. on under FDA product code LEL (Device, Sleep Assessment). FDA records list 9 510(k) clearances for Empatica S.r.l., from to . As of , FDA records show no recalls naming K252981.

Clearance record

Decision date
Received
(96 days to decision)
Product code
LEL Device, Sleep Assessment
Regulation
21 CFR 882.5050
Device class
Class II
Review panel
Neurology
Applicant
Empatica S.r.l. Via Stendhal, 36, Milan, IT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LEL

Trailing 12 months
1 clearance under product code LEL in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LEL, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260