Cleared Traditional

EmbraceMini

K252981 · Empatica S.R.L. · Neurology
Dec 2025
Decision
96d
Days
Class 2
Risk

About This 510(k) Submission

K252981 is an FDA 510(k) clearance for the EmbraceMini, a Device, Sleep Assessment (Class II — Special Controls, product code LEL), submitted by Empatica S.R.L. (Milan, IT). The FDA issued a Cleared decision on December 22, 2025, 96 days after receiving the submission on September 17, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5050.

Submission Details

510(k) Number K252981 FDA.gov
FDA Decision Cleared SESE
Date Received September 17, 2025
Decision Date December 22, 2025
Days to Decision 96 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code LEL — Device, Sleep Assessment
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5050