Cleared Traditional

K862377 - QMED SELF ADHERING ELECTRODE

K862377 is the FDA 510(k) clearance for QMED SELF ADHERING ELECTRODE by Qmed, Inc.. It is a Class 2 Neurology device (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

Submission Details

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.

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 147
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K862377.
STRAIGHT-LINE FINISH FOR IMPLANTABLE PULSE GENERA.
K881749 · Medtronic Vascular · Jul 1988
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TENZCARE(TM) SNAP ELECTRODE 6867
K864973 · 3M Company · Jan 1987
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