Cleared Traditional

K821539 - MEDICOTEST ELECTRODE PASTE

K821539 is the FDA 510(k) clearance for MEDICOTEST ELECTRODE PASTE by Medicotest, Inc.. It is a Class 2 Neurology device (product code GYB) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K821539 · Medicotest, Inc. · Neurology device
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Jul 1982
Decision
39d
Days
Class 2
Risk

K821539 is an FDA 510(k) clearance for the MEDICOTEST ELECTRODE PASTE. Classified as Media, Electroconductive (product code GYB), Class II - Special Controls.

Submitted by Medicotest, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 2, 1982 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1275 - 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 Medicotest, Inc. devices

Submission Details

510(k) Number K821539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1982
Decision Date July 02, 1982
Days to Decision 39 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 148d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GYB Media, Electroconductive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1275
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 - GYB Media, Electroconductive

All 29
Devices cleared under the same product code (GYB) and FDA review panel - the closest regulatory comparables to K821539.
SKIN PURE
K862799 · Nihon Kohden America, Inc. · Nov 1986
ELEFIX ELECTRODE CREAM
K860210 · Nihon Kohden America, Inc. · Jul 1986
CONTACT CONDUCTIVE ADHESIVE GEL COMPOSITION
K852956 · Parker Laboratories, Inc. · Aug 1985
ECG & ULTRASOUND GELS, CREAMS & LOTION
K803151 · Abco Dealers, Inc. · Dec 1980
SPECTRA R PAD
K791013 · Parker Laboratories, Inc. · Sep 1979
MEDI-TRACE EEG CREME
K790818 · Graphic Controls Corp. · Jun 1979