Cleared Traditional

K212325 - EEG-acp

K212325 is an FDA 510(k) clearance for EEG-acp, manufactured by Somnomedics GmbH. The device is a Class 2 Neurology device with product code GYB cleared through the Traditional 510(k) pathway after a 324-day FDA review.

K212325 · Somnomedics GmbH · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2022
Decision
324d
Days
Class 2
Risk

K212325 is an FDA 510(k) clearance for the EEG-acp. Classified as Media, Electroconductive (product code GYB), Class II - Special Controls.

Submitted by Somnomedics GmbH (Randersacker, DE). The FDA issued a Cleared decision on June 15, 2022 after a review of 324 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1275 - 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. Elevated predicate reliance profile. 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 Somnomedics GmbH devices

FDA 510(k) Submission Details - K212325

510(k) Number K212325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2021
Decision Date June 15, 2022
Days to Decision 324 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
176d slower than avg
Panel avg: 148d · This submission: 324d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GYB Device Classification - Class 2, Special Controls

Product Code GYB Media, Electroconductive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1275
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 - GYB Media, Electroconductive

All 28
Devices cleared under the same product code (GYB) and FDA review panel - the closest regulatory comparables to K212325.
Avologi Gel Primer (Model: Av25)
K220735 · Premier North America, Inc. · Sep 2023
Conductive Gel
K222770 · Top-Rank Health Care Co., Ltd. · Dec 2022
Conductive Gel
K221724 · Tone-A-Matic International, Inc. · Sep 2022
AC Cream - Conductive paste
K212326 · Spes Medica Srl · Dec 2021
GT5 conductive & abrasive gel
K212787 · Wuhan Greentek Pty , Ltd. · Nov 2021
DR-HO'S Electro Therapy Conductive Gel
K200402 · Guangzhou Xinbo Electronic Co., Ltd. · Nov 2020