Cleared Traditional

K945034 - CONMED ECG PATIENT SAFETY CABLES AND LEADWIRES-REMOVAL AND PERMANENTLY-ATTACHED LEADWIRES

K945034 is an FDA 510(k) clearance for CONMED ECG PATIENT SAFETY CABLES AND LE..., manufactured by Conmedcorp. The device is a Class 2 Cardiovascular device with product code DSA cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K945034 · Conmedcorp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1994
Decision
14d
Days
Class 2
Risk

K945034 is an FDA 510(k) clearance for the CONMED ECG PATIENT SAFETY CABLES AND LEADWIRES-REMOVAL AND PERMANENTLY-ATTACH.... Classified as Cable, Transducer And Electrode, Patient, (including Connector) (product code DSA), Class II - Special Controls.

Submitted by Conmedcorp (Utica, US). The FDA issued a Cleared decision on October 27, 1994 after a review of 14 days - a notably fast clearance 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: 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 Conmedcorp devices

FDA 510(k) Submission Details - K945034

510(k) Number K945034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1994
Decision Date October 27, 1994
Days to Decision 14 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 125d · This submission: 14d
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 83
Devices cleared under the same product code (DSA) and FDA review panel - the closest regulatory comparables to K945034.
3M RED DOT ECG LEAD WIRES A
K954900 · Minnesota Mining and Mfg. Co. · Jul 1996
MODEL 5471 & 5471L STERILE DISPOSABLE PATIENT CABLE ASSEMBLIES
K960446 · Medtronic Vascular · May 1996
TRONOMATE PATIENT CABLE & LEADWIRE SYSTEM
K952659 · Tronomed, Inc. · Jan 1996
CONMED ECG PATIENT CABLES AND LEADWIRES
K933649 · Conmedcorp · Feb 1994
DISPOSABLE SURGICAL EXTENSION CABLE MODEL S-101
K922009 · Remington Medical, Inc. · Feb 1993
MODEL 4280 SURGICAL EXTENSION CABLE
K922899 · Pace Medical · Dec 1992