Cleared Traditional

K925466 - CONDUCT ALOE GEL

K925466 is the FDA 510(k) clearance for CONDUCT ALOE GEL by Uni-Patch, Inc.. It is a Class 2 Neurology device (product code GYB) cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K925466 · Uni-Patch, Inc. · Neurology device
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Aug 1993
Decision
301d
Days
Class 2
Risk

K925466 is an FDA 510(k) clearance for the CONDUCT ALOE GEL, #UP239-8FL. OZ/#UP245 G-1 GALLON. Classified as Media, Electroconductive (product code GYB), Class II - Special Controls.

Submitted by Uni-Patch, Inc. (Wabasha, US). The FDA issued a Cleared decision on August 26, 1993 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Uni-Patch, Inc. devices

Submission Details

510(k) Number K925466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1992
Decision Date August 26, 1993
Days to Decision 301 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
153d slower than avg
Panel avg: 148d · This submission: 301d
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 25
Devices cleared under the same product code (GYB) and FDA review panel - the closest regulatory comparables to K925466.
TEN-20 CONDUCTIVE PASTE GEL
K933799 · Cadwell Laboratories, Inc. · May 1994
OMNI PREP GEL
K933797 · Cadwell Laboratories, Inc. · May 1994
LECTRON II CONDUCTIVE GEL/CADWELL ELECTRODE GEL
K933804 · Cadwell Laboratories, Inc. · Mar 1994
ELECTROCONDUCTIVE MEDIA
K904377 · Henley Intl. · Nov 1991
CHEMPAD(TM), ELECTROCONDUCTIVE MEDIA (882.1275)
K901630 · Henley Intl. · Jul 1990
TENS PREP
K893604 · Smith & Nephew United, Inc. · Nov 1989