Cleared Traditional

K915333 - ELECTRODE USING PROMEON RG-60 SERIES GEL

K915333 is the FDA 510(k) clearance for ELECTRODE USING PROMEON RG-60 SERIES GEL by Labeltape Meditect, Inc.. It is a Class 2 Neurology device (product code GXY) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K915333 · Labeltape Meditect, Inc. · Neurology device
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Jan 1992
Decision
49d
Days
Class 2
Risk

K915333 is an FDA 510(k) clearance for the ELECTRODE USING PROMEON RG-60 SERIES GEL. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Labeltape Meditect, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on January 14, 1992 after a review of 49 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Labeltape Meditect, Inc. devices

Submission Details

510(k) Number K915333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1991
Decision Date January 14, 1992
Days to Decision 49 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
99d faster than avg
Panel avg: 148d · This submission: 49d
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 K915333.
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K901102 · Empi · Mar 1990