Cleared Traditional

K970796 - 3M RED DOT 2560 & 2570 MONITORING ELECT...

K970796 is an FDA 510(k) clearance for 3M RED DOT 2560 & 2570 MONITORING ELECT..., 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 36-day FDA review.

K970796 · 3M Healthcare · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
36d
Days
Class 2
Risk

K970796 is an FDA 510(k) clearance for the 3M RED DOT 2560 & 2570 MONITORING ELECTRODES. 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 April 9, 1997 after a review of 36 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.

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FDA 510(k) Submission Details - K970796

510(k) Number K970796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1997
Decision Date April 09, 1997
Days to Decision 36 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
89d faster than avg
Panel avg: 125d · This submission: 36d
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 K970796.
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