Cleared Traditional

K252981 - EmbraceMini (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K252981 is an FDA 510(k) clearance for the EmbraceMini. Classified as Device, Sleep Assessment (product code LEL), Class II - Special Controls.

Submitted by Empatica S.R.L. (Milan, IT). The FDA issued a Cleared decision on December 22, 2025 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5050 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Empatica S.R.L. devices

Submission Details

510(k) Number K252981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 148d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LEL Device, Sleep Assessment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - LEL Device, Sleep Assessment

All 18
Devices cleared under the same product code (LEL) and FDA review panel - the closest regulatory comparables to K252981.
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