Cleared Traditional

K223676 - SomniCheck

K223676 is an FDA 510(k) clearance for SomniCheck, manufactured by Brainmatterz, LLC. The device is a Class 2 Neurology device with product code GWL cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K223676 · Brainmatterz, LLC · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2023
Decision
175d
Days
Class 2
Risk

K223676 is an FDA 510(k) clearance for the SomniCheck. Classified as Amplifier, Physiological Signal (product code GWL), Class II - Special Controls.

Submitted by Brainmatterz, LLC (Richmond, US). The FDA issued a Cleared decision on June 1, 2023 after a review of 175 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1835 - 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 Brainmatterz, LLC devices

FDA 510(k) Submission Details - K223676

510(k) Number K223676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2022
Decision Date June 01, 2023
Days to Decision 175 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
27d slower than avg
Panel avg: 148d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWL Device Classification - Class 2, Special Controls

Product Code GWL Amplifier, Physiological Signal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1835
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 - GWL Amplifier, Physiological Signal

All 18
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