Cleared Traditional

K803151 - ECG & ULTRASOUND GELS

K803151 is the FDA 510(k) clearance for ECG & ULTRASOUND GELS by Abco Dealers, Inc.. It is a Class 2 Neurology device (product code GYB) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K803151 · Abco Dealers, Inc. · Neurology device
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Dec 1980
Decision
18d
Days
Class 2
Risk

K803151 is an FDA 510(k) clearance for the ECG & ULTRASOUND GELS, CREAMS & LOTION. Classified as Media, Electroconductive (product code GYB), Class II - Special Controls.

Submitted by Abco Dealers, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 30, 1980 after a review of 18 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 Abco Dealers, Inc. devices

Submission Details

510(k) Number K803151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1980
Decision Date December 30, 1980
Days to Decision 18 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
130d faster than avg
Panel avg: 148d · This submission: 18d
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 23
Devices cleared under the same product code (GYB) and FDA review panel - the closest regulatory comparables to K803151.
CHEMPAD(TM), ELECTROCONDUCTIVE MEDIA (882.1275)
K901630 · Henley Intl. · Jul 1990
SKIN PURE
K862799 · Nihon Kohden America, Inc. · Nov 1986
ELEFIX ELECTRODE CREAM
K860210 · Nihon Kohden America, Inc. · Jul 1986
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