Cleared Traditional

K920674 - ELECTROLINK

K920674 is an FDA 510(k) clearance for ELECTROLINK, manufactured by Kold Products. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 349-day FDA review.

K920674 · Kold Products · Neurology device
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Jan 1993
Decision
349d
Days
Class 2
Risk

K920674 is an FDA 510(k) clearance for the ELECTROLINK. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Kold Products (Elkhart, US). The FDA issued a Cleared decision on January 28, 1993 after a review of 349 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Kold Products devices

FDA 510(k) Submission Details - K920674

510(k) Number K920674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1992
Decision Date January 28, 1993
Days to Decision 349 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
201d slower than avg
Panel avg: 148d · This submission: 349d
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 317
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K920674.
PHOTOSTRESS RECOVERY TESTER
K933814 · Storz Instrument Co. · Dec 1993
MONOTRODE CUTANEOUS ELECTRODE
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REUSABLE FINGER CLIP RECORDING ELECTRODE
K925706 · Chalgren Enterprises, Inc. · Feb 1993
BIO-DETEK TRACERITE EEG ELECTRODE
K920264 · Bio-Detek, Inc. · Jun 1992
ELECTRODE
K912643 · Skylark Device Co., Ltd. · Feb 1992
K-STIM
K913031 · Katecho, Inc. · Jan 1992