Cleared Traditional

K934333 - 3M RED DOT 2237 STICKY GEL MONITORING E...

K934333 is an FDA 510(k) clearance for 3M RED DOT 2237 STICKY GEL MONITORING E..., 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 303-day FDA review.

K934333 · 3M Medical Products Group · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
303d
Days
Class 2
Risk

K934333 is an FDA 510(k) clearance for the 3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE. 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 July 7, 1994 after a review of 303 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Medical Products Group devices

FDA 510(k) Submission Details - K934333

510(k) Number K934333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1993
Decision Date July 07, 1994
Days to Decision 303 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
178d slower than avg
Panel avg: 125d · This submission: 303d
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 K934333.
EKG VEST
K932903 · Cardiotronics, Inc. · Feb 1995
QUIK COMBO
K943301 · Physio-Control Corp. · Feb 1995
MEDI-TRACE NEONATAL ECG ELECTRODE WITH PREATTACHED LEADWIRE
K945214 · Graphic Controls Corp. · Nov 1994
3M RED DOT 2234 RADIOLUCENT MONITORING ELECTRODE
K930312 · 3M Health Care, Ltd. · Sep 1993
3M RED DOT 2330 RESTING EKG ELECTRODE
K932454 · 3M Health Care, Ltd. · Aug 1993
TRACET T-6000
K930258 · Lectec Corp. · Apr 1993