Cleared Traditional

K200540 - BRAINSTREAM Disposable Deep Cup EEG Electrodes

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

K200540 · Conmed Corporation · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K200540

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.

GXY Device Classification - Class 2, Special Controls

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 290
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