Cleared Traditional

K974445 - 3M RED DOT RESTING EKG ELECTRODE

K974445 is an FDA 510(k) clearance for 3M RED DOT RESTING EKG ELECTRODE, manufactured by 3M Healthcare. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K974445 · 3M Healthcare · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
243d
Days
Class 2
Risk

K974445 is an FDA 510(k) clearance for the 3M RED DOT RESTING EKG ELECTRODE, CATALOG 2360. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by 3M Healthcare (St. Paul, US). The FDA issued a Cleared decision on July 26, 1998 after a review of 243 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 3M Healthcare devices

FDA 510(k) Submission Details - K974445

510(k) Number K974445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1997
Decision Date July 26, 1998
Days to Decision 243 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d slower than avg
Panel avg: 125d · This submission: 243d
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 118
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K974445.
AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S
K041026 · Ambu, Inc. · Jun 2004
ECG ELECTRODE (VARIOUS)
K991105 · Conmedcorp · Nov 1999
MEDI-TRACE 4103 NEONATAL ELECTRODE
K981964 · Graphic Controls Corp. · Nov 1998
EXACTRACE ADULT FOAM MONITORING ECG ELECTRODE CONMED MODEL 1510 AND INSTATRACE ADULT DIAPHORETIC FOAM ECG ELECTRODE CONM
K963787 · Conmedcorp · Mar 1997
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