Cleared Traditional

K963787 - EXACTRACE ADULT FOAM MONITORING ECG ELECTRODE CONMED MODEL 1510 AND INSTATRACE ADULT DIAPHORETIC FOAM ECG ELECTRODE CONM

K963787 is an FDA 510(k) clearance for EXACTRACE ADULT FOAM MONITORING ECG ELE..., manufactured by Conmedcorp. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K963787 · Conmedcorp · Cardiovascular device
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Mar 1997
Decision
172d
Days
Class 2
Risk

K963787 is an FDA 510(k) clearance for the EXACTRACE ADULT FOAM MONITORING ECG ELECTRODE CONMED MODEL 1510 AND INSTATRAC.... Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Conmedcorp (Utica, US). The FDA issued a Cleared decision on March 11, 1997 after a review of 172 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 - K963787

510(k) Number K963787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1996
Decision Date March 11, 1997
Days to Decision 172 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
47d slower than avg
Panel avg: 125d · This submission: 172d
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 202
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K963787.
3M RED DOT 2234 & 2266 RADIOLUCENT MONITORING ELECTRODES
K971444 · 3M Medical Products Group · Jun 1997
STEALTHSHIELD
K970755 · Vital Connections, Inc. · Apr 1997
3M RED DOT 2560 & 2570 MONITORING ELECTRODES
K970796 · 3M Healthcare · Apr 1997
NOAH MONITORING ELECTRODE SYSTEM
K970125 · Contour Medical Technology, Inc. · Mar 1997
VERSATEC 310 ELECTRODE
K963975 · Versatec, Inc. · Jan 1997
CONDUCTIVE HYDROGEL POLYMER BASED ON U & C SERIES ELECTRODES
K963159 · Cmc Sense-It, Inc. · Dec 1996