Cleared Traditional

K961643 - MEDICOTEST ECG ELECTRODES

K961643 is an FDA 510(k) clearance for MEDICOTEST ECG ELECTRODES, manufactured by Medicotest, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K961643

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
Combination Product No
PCCP Authorized No
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.

DRX Device Classification - Class 2, Special Controls

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 188
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K961643.
NOAH MONITORING ELECTRODE SYSTEM
K970125 · Contour Medical Technology, Inc. · Mar 1997
VERSATEC 310 ELECTRODE
K963975 · Versatec, Inc. · Jan 1997
CONDUCTIVE HYDROGEL POLYMER BASED ON U & C SERIES ELECTRODES
K963159 · Cmc Sense-It, Inc. · Dec 1996
TRACE RITE SOLID GEL ECG ELECTRODES
K964213 · Bio-Detek, Inc. · Nov 1996
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