Cleared Traditional

K821438 - RED DOT MONITORING ELECTRODES #2260/65

K821438 is an FDA 510(k) clearance for RED DOT MONITORING ELECTRODES #2260/65, manufactured by 3M Company. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K821438 · 3M Company · Cardiovascular device
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May 1982
Decision
12d
Days
Class 2
Risk

K821438 is an FDA 510(k) clearance for the RED DOT MONITORING ELECTRODES #2260/65. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by 3M Company (White City, US). The FDA issued a Cleared decision on May 25, 1982 after a review of 12 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 3M Company devices

FDA 510(k) Submission Details - K821438

510(k) Number K821438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1982
Decision Date May 25, 1982
Days to Decision 12 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 125d · This submission: 12d
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 179
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K821438.
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
MEDITRACE PELLET ELECTRODE
K821137 · Graphic Controls Corp. · May 1982
PIONEER II BACK PLATE ELECTRODE
K820122 · Life Science Instrumentation, Inc. · Mar 1982
THE NEW 1600 ELECTRODE
K812878 · Andover Medical, Inc. · Nov 1981