Cleared Traditional

K200540 - BRAINSTREAM Disposable Deep Cup EEG Ele...

K200540 is the FDA 510(k) clearance for BRAINSTREAM Disposable Deep Cup EEG Ele... by Conmed Corporation. It is a Class 2 Neurology device (product code GXY) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K200540 · Conmed Corporation · Neurology device
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Jun 2020
Decision
90d
Days
Class 2
Risk

K200540 is an FDA 510(k) clearance for the BRAINSTREAM Disposable Deep Cup EEG Electrodes. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Conmed Corporation (Utica, US). The FDA issued a Cleared decision on June 1, 2020 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - 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 Conmed Corporation devices

Submission Details

510(k) Number K200540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2020
Decision Date June 01, 2020
Days to Decision 90 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
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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 - GXY Electrode, Cutaneous

All 141
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K200540.
NeuroCap (Model DEC22)
K202913 · Memory MD, Inc. · Mar 2021
MR Conditional Sticky Pad Electrode
K203079 · Rhythmlink International, LLC · Feb 2021
Jiajian Self-Adhesive Electrode
K192568 · Wuxi Jiajian Medical Instrument Co., Ltd. · Feb 2021
Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III)
K190118 · Guangzhou Xinbo Electronic Co., Ltd. · May 2020
Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)
K200162 · Wuhan Greentek Pty , Ltd. · Apr 2020
Disposable Gold Cup EEG Electrodes
K192564 · Dymedix Diagnostics, Inc. · Jan 2020