Cleared Traditional

K862377 - QMED SELF ADHERING ELECTRODE

K862377 is an FDA 510(k) clearance for QMED SELF ADHERING ELECTRODE, manufactured by Qmed, Inc.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K862377 · Qmed, Inc. · Neurology device
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Sep 1986
Decision
94d
Days
Class 2
Risk

K862377 is an FDA 510(k) clearance for the QMED SELF ADHERING ELECTRODE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Qmed, Inc. (Louisville, US). The FDA issued a Cleared decision on September 26, 1986 after a review of 94 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 Qmed, Inc. devices

FDA 510(k) Submission Details - K862377

510(k) Number K862377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1986
Decision Date September 26, 1986
Days to Decision 94 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 148d · This submission: 94d
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 301
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K862377.
DISPOSABLE, PIN-CONN. POLYMER-GEL ELECT. FOR TENS
K871026 · Labeltape Meditect, Inc. · Apr 1987
TENZCARE(TM) SNAP ELECTRODE 6867
K864973 · 3M Company · Jan 1987
EM TENS WINDOW ELECTRODES
K864032 · Electromed Intl., Ltd. · Dec 1986
TENZCARE SNAP ELECTRODE, NO. 6865
K863307 · 3M Company · Sep 1986
POLYHESIVE R ELECTRODES/TENS MUSCLE STIM ELEC THER
K863035 · Valleylab, Inc. · Sep 1986
VERSA STIM
K862718 · Conmedcorp · Sep 1986