Cleared Traditional

K902080 - RED DOT 2269 INFANT MONITORING ELECTRODE

K902080 is an FDA 510(k) clearance for RED DOT 2269 INFANT MONITORING ELECTRODE, 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 71-day FDA review.

K902080 · 3M Company · Cardiovascular device
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Jul 1990
Decision
71d
Days
Class 2
Risk

K902080 is an FDA 510(k) clearance for the RED DOT 2269 INFANT MONITORING ELECTRODE. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by 3M Company (Cottae Grove, US). The FDA issued a Cleared decision on July 18, 1990 after a review of 71 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.

FDA 510(k) Submission Details - K902080

510(k) Number K902080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1990
Decision Date July 18, 1990
Days to Decision 71 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
54d faster than avg
Panel avg: 125d · This submission: 71d
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 324
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K902080.
ELECTRO BLUE ECG ELECTRODE-PEDIATRIC CLOTH
K902738 · Labeltape Meditect, Inc. · Sep 1990
NF-50-E DISPOSABLE ECG ELECTRODE
K902407 · Medicotest, Inc. · Jul 1990
MODEL 1730 NEOTRODE WITH ATTACHED LEADWIRE
K901555 · Medtronic Vascular · Jul 1990
CLASSIC ECG/STIMULATING NO. 1700 SERIES
K900519 · Classic Medical Products, Inc. · Mar 1990
ELECTROTRACE DISPOSABLE AG/AGCL EKG MONITOR ELEC.
K896569 · Jason Marketing Co. · Jan 1990
RED DOT CARDIAC SENSOR SYSTEM
K896155 · 3M Company · Dec 1989
K902080 · RED DOT 2269 INFANT MONITORING ELECTRODE
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