Cleared Traditional

K971444 - 3M RED DOT 2234 & 2266 RADIOLUCENT MONI...

K971444 is an FDA 510(k) clearance for 3M RED DOT 2234 & 2266 RADIOLUCENT MONI..., manufactured by 3M Medical Products Group. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K971444 · 3M Medical Products Group · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
51d
Days
Class 2
Risk

K971444 is an FDA 510(k) clearance for the 3M RED DOT 2234 & 2266 RADIOLUCENT MONITORING ELECTRODES. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by 3M Medical Products Group (St Paul, US). The FDA issued a Cleared decision on June 11, 1997 after a review of 51 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 Medical Products Group devices

FDA 510(k) Submission Details - K971444

510(k) Number K971444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1997
Decision Date June 11, 1997
Days to Decision 51 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
74d faster than avg
Panel avg: 125d · This submission: 51d
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 92
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K971444.
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