Cleared Traditional

K782055 - CREAM

K782055 is the FDA 510(k) clearance for CREAM by Parker Laboratories, Inc.. It is a Class 2 Neurology device (product code GYB) cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K782055 · Parker Laboratories, Inc. · Neurology device
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Mar 1979
Decision
100d
Days
Class 2
Risk

K782055 is an FDA 510(k) clearance for the CREAM, SIGNA. Classified as Media, Electroconductive (product code GYB), Class II - Special Controls.

Submitted by Parker Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 21, 1979 after a review of 100 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Parker Laboratories, Inc. devices

Submission Details

510(k) Number K782055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1978
Decision Date March 21, 1979
Days to Decision 100 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 148d · This submission: 100d
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 24
Devices cleared under the same product code (GYB) and FDA review panel - the closest regulatory comparables to K782055.
ECG & ULTRASOUND GELS, CREAMS & LOTION
K803151 · Abco Dealers, Inc. · Dec 1980
MEDI-TRACE EEG CREME
K790818 · Graphic Controls Corp. · Jun 1979
EEG GEL
K781493 · Graphic Controls Corp. · Apr 1979
CONDUCTIVE CREAM-500
K770623 · Graphic Controls Corp. · Apr 1977
CONDUCTIVITY GEL W/POTASSIUM CHLORIDE
K770622 · Graphic Controls Corp. · Apr 1977