Cleared Traditional

K921579 - BR-50-J DISPOSABLE ECG ELECTRODE

K921579 is an FDA 510(k) clearance for BR-50-J DISPOSABLE ECG ELECTRODE, 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 54-day FDA review.

K921579 · Medicotest, Inc. · Cardiovascular device
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May 1992
Decision
54d
Days
Class 2
Risk

K921579 is an FDA 510(k) clearance for the BR-50-J DISPOSABLE ECG ELECTRODE. 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 May 26, 1992 after a review of 54 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.

View all Medicotest, Inc. devices

FDA 510(k) Submission Details - K921579

510(k) Number K921579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1992
Decision Date May 26, 1992
Days to Decision 54 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
71d faster than avg
Panel avg: 125d · This submission: 54d
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 189
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K921579.
MODEL 1300 SOFTRACE II ELECTRODE
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ECG ELECTRODE
K923558 · Lectec Corp. · Feb 1993
DRIGEL DEFIBRILLATOR/SYNCHRONIZED COARDIOVERSION
K921207 · Physiometrix, Inc. · Oct 1992
MODEL #810 STEALTH-STIM ADULT STIMULATION PADS
K913226 · Cardiotronics, Inc. · Sep 1991
TRACETS SME 5000
K912450 · Lectec Corp. · Aug 1991
RT40 RADIO TRANSLUCENT
K912714 · Bio-Detek, Inc. · Jul 1991