Cleared Traditional

K813176 - GEL ELECTRODE

K813176 is the FDA 510(k) clearance for GEL ELECTRODE by Dyn-A-Med Products. It is a Class 2 Cardiovascular device (product code DRX) cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K813176 · Dyn-A-Med Products · Cardiovascular device
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Dec 1981
Decision
47d
Days
Class 2
Risk

K813176 is an FDA 510(k) clearance for the GEL ELECTRODE. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Dyn-A-Med Products (Mchenry, US). The FDA issued a Cleared decision on December 29, 1981 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2360 - the FDA cardiovascular device oversight 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.

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Submission Details

510(k) Number K813176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1981
Decision Date December 29, 1981
Days to Decision 47 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 125d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRX Electrode, Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2360
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DRX Electrode, Electrocardiograph

All 83
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K813176.
QUIK - PREP2 ELECTRODE
K821757 · Quinton, Inc. · Jul 1982
RED DOT MONITORING ELECTRODES #2260/65
K821438 · 3M Company · May 1982
MEDITRACE PELLET ELECTRODE
K821137 · Graphic Controls Corp. · May 1982
QUINTON LTE ELECTRODE
K810563 · Quinton, Inc. · Mar 1981
INFANT ECG ELECTRODE #60-1029
K810102 · Aspen Laboratories, Inc. · Jan 1981
ADULT ECG ELECTRODE #60-0724
K810103 · Aspen Laboratories, Inc. · Jan 1981