Cleared Traditional

K782055 - CREAM, SIGNA

K782055 is an FDA 510(k) clearance for CREAM, manufactured by Parker Laboratories, Inc.. The device is a Class 2 Neurology device with 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

FDA 510(k) Submission Details - K782055

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
Combination Product No
PCCP Authorized No
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.

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 39
Devices cleared under the same product code (GYB) and FDA review panel - the closest regulatory comparables to K782055.
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
SIGNAPAD
K780973 · Parker Laboratories, Inc. · Jul 1978
CONDUCTIVE CREAM-500
K770623 · Graphic Controls Corp. · Apr 1977
CONDUCTIVITY GEL W/POTASSIUM CHLORIDE
K770622 · Graphic Controls Corp. · Apr 1977