Cleared Traditional

K954900 - 3M RED DOT ECG LEAD WIRES A

K954900 is an FDA 510(k) clearance for 3M RED DOT ECG LEAD WIRES A, manufactured by Minnesota Mining and Mfg. Co.. The device is a Class 2 Cardiovascular device with product code DSA cleared through the Traditional 510(k) pathway after a 264-day FDA review.

K954900 · Minnesota Mining and Mfg. Co. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
264d
Days
Class 2
Risk

K954900 is an FDA 510(k) clearance for the 3M RED DOT ECG LEAD WIRES A. Classified as Cable, Transducer And Electrode, Patient, (including Connector) (product code DSA), Class II - Special Controls.

Submitted by Minnesota Mining and Mfg. Co. (St. Paul, US). The FDA issued a Cleared decision on July 15, 1996 after a review of 264 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2900 - 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.

FDA 510(k) Submission Details - K954900

510(k) Number K954900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1995
Decision Date July 15, 1996
Days to Decision 264 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
139d slower than avg
Panel avg: 125d · This submission: 264d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSA Device Classification - Class 2, Special Controls

Product Code DSA Cable, Transducer And Electrode, Patient, (including Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2900
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 - DSA Cable, Transducer And Electrode, Patient, (including Connector)

All 92
Devices cleared under the same product code (DSA) and FDA review panel - the closest regulatory comparables to K954900.
AFFINITY MEDICAL PATIENT CABLE SYSTEM
K980806 · Affinity Medical Technologies, LLC · Mar 1998
MULTI-LINK CABLE AND LEAD WIRE SYSTEMS
K980582 · Marquette Medical Systems, Inc. · Mar 1998
SAFE CONNECT SURGICAL CABLE (S-101-97/S-201-97/FL-601-97)
K971968 · Remington Medical, Inc. · Jul 1997
MODEL 5471 & 5471L STERILE DISPOSABLE PATIENT CABLE ASSEMBLIES
K960446 · Medtronic Vascular · May 1996
TRONOMATE PATIENT CABLE & LEADWIRE SYSTEM
K952659 · Tronomed, Inc. · Jan 1996
ARBO DIAGNOSTIC ECG PATIENT CABLES & LEADWIRES ARBO SHIELDED MULTI-LEAD CABLE & LEAD SYSTEM
K940323 · Arbo Medical, Inc. · Apr 1995
K954900 · 3M RED DOT ECG LEAD WIRES A
Download PDF FDA Summary Minnesota Mining and …