Cleared Traditional

K192564 - Disposable Gold Cup EEG Electrodes

K192564 is the FDA 510(k) clearance for Disposable Gold Cup EEG Electrodes by Dymedix Diagnostics, Inc.. It is a Class 2 Neurology device (product code GXY) cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K192564 · Dymedix Diagnostics, Inc. · Neurology device
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Jan 2020
Decision
125d
Days
Class 2
Risk

K192564 is an FDA 510(k) clearance for the Disposable Gold Cup EEG Electrodes. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Dymedix Diagnostics, Inc. (Shoreview, US). The FDA issued a Cleared decision on January 21, 2020 after a review of 125 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 Dymedix Diagnostics, Inc. devices

Submission Details

510(k) Number K192564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2019
Decision Date January 21, 2020
Days to Decision 125 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
23d faster than avg
Panel avg: 148d · This submission: 125d
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 K192564.
BRAINSTREAM Disposable Deep Cup EEG Electrodes
K200540 · Conmed Corporation · Jun 2020
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
Myo Plus
K191179 · Otto Bock Healthcare Products GmbH · Sep 2019
EEG Electrode Template
K191225 · Rhythmlink International, LLC · Aug 2019
Wrap accessory electrodes
K190617 · Hi-Dow International, Inc. · Jul 2019