Cleared Traditional

K961643 - MEDICOTEST ECG ELECTRODES

K961643 is the FDA 510(k) clearance for MEDICOTEST ECG ELECTRODES by Medicotest, Inc.. It is a Class 2 Cardiovascular device (product code DRX) cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K961643 · Medicotest, Inc. · Cardiovascular device
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Dec 1996
Decision
224d
Days
Class 2
Risk

K961643 is an FDA 510(k) clearance for the MEDICOTEST ECG ELECTRODES. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Medicotest, Inc. (St. Louis, US). The FDA issued a Cleared decision on December 9, 1996 after a review of 224 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Medicotest, Inc. devices

Submission Details

510(k) Number K961643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1996
Decision Date December 09, 1996
Days to Decision 224 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d slower than avg
Panel avg: 125d · This submission: 224d
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 84
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K961643.
ECG ELECTRODE (VARIOUS)
K991105 · Conmedcorp · Nov 1999
MEDI-TRACE 4103 NEONATAL ELECTRODE
K981964 · Graphic Controls Corp. · Nov 1998
EXACTRACE ADULT FOAM MONITORING ECG ELECTRODE CONMED MODEL 1510 AND INSTATRACE ADULT DIAPHORETIC FOAM ECG ELECTRODE CONM
K963787 · Conmedcorp · Mar 1997
MEDI-TRACE 5700 RESTING ECG ELECTRODE
K963151 · Graphic Controls Corp. · Nov 1996
MEDI-TRACE 3600 SERIES OF ECG MONITORING ELECTRODE
K963038 · Graphic Controls Corp. · Nov 1996
MEDI-TRACE 200, MEDI-TRACE 200-30
K960968 · Graphic Controls Corp. · Oct 1996