Cleared Traditional

K802650 - UCA LOTION PRODUCT REFORMULATION

K802650 is an FDA 510(k) clearance for UCA LOTION PRODUCT REFORMULATION, manufactured by Vanaray Laboratories, Inc.. The device is a Class 2 Neurology device with product code GYB cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K802650 · Vanaray Laboratories, Inc. · Neurology device
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Nov 1980
Decision
23d
Days
Class 2
Risk

K802650 is an FDA 510(k) clearance for the UCA LOTION PRODUCT REFORMULATION. Classified as Media, Electroconductive (product code GYB), Class II - Special Controls.

Submitted by Vanaray Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 12, 1980 after a review of 23 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 Vanaray Laboratories, Inc. devices

FDA 510(k) Submission Details - K802650

510(k) Number K802650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1980
Decision Date November 12, 1980
Days to Decision 23 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
125d faster than avg
Panel avg: 148d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GYB Device Classification - Class 2, Special Controls

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 40
Devices cleared under the same product code (GYB) and FDA review panel - the closest regulatory comparables to K802650.
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
EEG GEL
K781493 · Graphic Controls Corp. · Apr 1979