Cleared Traditional

K954388 - CONMED 2710 CLEARTRACE 2 LT MONITORING ...

K954388 is an FDA 510(k) clearance for CONMED 2710 CLEARTRACE 2 LT MONITORING ..., manufactured by Conmedcorp. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K954388 · Conmedcorp · Cardiovascular device
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Feb 1996
Decision
140d
Days
Class 2
Risk

K954388 is an FDA 510(k) clearance for the CONMED 2710 CLEARTRACE 2 LT MONITORING ECG ELECTRODE. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Conmedcorp (Dayton, US). The FDA issued a Cleared decision on February 6, 1996 after a review of 140 days - within the typical 510(k) review window.

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 - K954388

510(k) Number K954388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1995
Decision Date February 06, 1996
Days to Decision 140 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
15d slower than avg
Panel avg: 125d · This submission: 140d
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 K954388.
MEDI-TRACE RADIOLUCENT
K961395 · Graphic Controls Corp. · Jun 1996
CONMED ECG/EKG ELECTRODES
K954389 · Conmedcorp · May 1996
CONMED EKG STRIPPER
K960264 · Conmedcorp · Apr 1996
MEDI-TRACE(R) 500 ECG ELECTRODE
K945479 · Graphic Controls Corp. · Jul 1995
GRAPHIC CONTROLS PROTRACE ECG ELECTRODE
K950485 · Graphic Controls Corp. · Jul 1995
GRAPHIC CONTROLS BIOTAC ECO ELECTRODE
K950488 · Graphic Controls Corp. · Jul 1995