Cleared Traditional

K191225 - EEG Electrode Template

K191225 is an FDA 510(k) clearance for EEG Electrode Template, manufactured by Rhythmlink International, LLC. 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.

K191225 · Rhythmlink International, LLC · Neurology device
Download Printable Device Report (PDF)
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Aug 2019
Decision
90d
Days
Class 2
Risk

K191225 is an FDA 510(k) clearance for the EEG Electrode Template. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Rhythmlink International, LLC (Columbia, US). The FDA issued a Cleared decision on August 5, 2019 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 Rhythmlink International, LLC devices

FDA 510(k) Submission Details - K191225

510(k) Number K191225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2019
Decision Date August 05, 2019
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 187
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K191225.
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
Myo Plus
K191179 · Otto Bock Healthcare Products GmbH · Sep 2019
Wrap accessory electrodes
K190617 · Hi-Dow International, Inc. · Jul 2019
ELECTRODES PAD
K190700 · Shenzhen Bestpad Technology Development Co., Ltd. · Jun 2019
COMPLETE CONTROL System Gen2
K191083 · Coapt, LLC · May 2019