Cleared Traditional

K954389 - CONMED ECG/EKG ELECTRODES

K954389 is an FDA 510(k) clearance for CONMED ECG/EKG ELECTRODES, manufactured by Conmedcorp. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K954389 · Conmedcorp · Cardiovascular device
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May 1996
Decision
240d
Days
Class 2
Risk

K954389 is an FDA 510(k) clearance for the CONMED ECG/EKG ELECTRODES. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Conmedcorp (Utica, US). The FDA issued a Cleared decision on May 16, 1996 after a review of 240 days - an extended review 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: 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.

View all Conmedcorp devices

FDA 510(k) Submission Details - K954389

510(k) Number K954389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1995
Decision Date May 16, 1996
Days to Decision 240 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
115d slower than avg
Panel avg: 125d · This submission: 240d
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 117
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K954389.
QUICKELS QS 200 SYSTEM
K954772 · Ferguson Medical · Jul 1996
QUICKELS QS 100 SYSTEM
K954773 · Ferguson Medical · Jul 1996
MEDI-TRACE RADIOLUCENT
K961395 · Graphic Controls Corp. · Jun 1996
CONMED EKG STRIPPER
K960264 · Conmedcorp · Apr 1996
CONMED 2710 CLEARTRACE 2 LT MONITORING ECG ELECTRODE
K954388 · Conmedcorp · Feb 1996
MEDI-TRACE(R) 500 ECG ELECTRODE
K945479 · Graphic Controls Corp. · Jul 1995