Cleared Traditional

MR Conditional Sticky Pad Electrode (K203079) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K203079 · Rhythmlink International, LLC · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2021
Decision
119d
Days
Class 2
Risk

K203079 is an FDA 510(k) clearance for the MR Conditional Sticky Pad Electrode. 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 February 9, 2021 after a review of 119 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

Submission Details

510(k) Number K203079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 2020
Decision Date February 09, 2021
Days to Decision 119 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
29d faster than avg
Panel avg: 148d · This submission: 119d
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 97
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K203079.
BioWave BioWraps
K203158 · Biowave Corporation · Jul 2021
Well-Life Garment Electrodes (GM Series)
K200942 · Well-Life Healthcare Limited · Jun 2021
NeuroCap (Model DEC22)
K202913 · Memory MD, Inc. · Mar 2021
Jiajian Self-Adhesive Electrode
K192568 · Wuxi Jiajian Medical Instrument Co., Ltd. · Feb 2021
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