Cleared Traditional

K821506 - MEDICOTEST ECG ELECTRODES

K821506 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 27-day FDA review.

K821506 · Medicotest, Inc. · Cardiovascular device
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Jun 1982
Decision
27d
Days
Class 2
Risk

K821506 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. (Mchenry, US). The FDA issued a Cleared decision on June 17, 1982 after a review of 27 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

Submission Details

510(k) Number K821506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1982
Decision Date June 17, 1982
Days to Decision 27 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 125d · This submission: 27d
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 K821506.
CENTURION ELECTRODE BELT
K821802 · Clinical Data, Inc. · Jul 1982
LDS MONITORING ELECTRODE
K821846 · Life Design Systems, Inc. · Jul 1982
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