Cleared Traditional

K964213 - TRACE RITE SOLID GEL ECG ELECTRODES

K964213 is the FDA 510(k) clearance for TRACE RITE SOLID GEL ECG ELECTRODES by Bio-Detek, Inc.. It is a Class 2 Cardiovascular device (product code DRX) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K964213 · Bio-Detek, Inc. · Cardiovascular device
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Nov 1996
Decision
34d
Days
Class 2
Risk

K964213 is an FDA 510(k) clearance for the TRACE RITE SOLID GEL ECG ELECTRODES. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Bio-Detek, Inc. (Pawtucket, US). The FDA issued a Cleared decision on November 25, 1996 after a review of 34 days - a notably fast clearance 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: 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 Bio-Detek, Inc. devices

Submission Details

510(k) Number K964213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1996
Decision Date November 25, 1996
Days to Decision 34 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 125d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 45
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K964213.
MACTRODE 3
K060661 · Ge Medical Systems Information Technologies · Apr 2006
ECG ELECTRODE (VARIOUS)
K991105 · Conmedcorp · Nov 1999
EXACTRACE ADULT FOAM MONITORING ECG ELECTRODE CONMED MODEL 1510 AND INSTATRACE ADULT DIAPHORETIC FOAM ECG ELECTRODE CONM
K963787 · Conmedcorp · Mar 1997
BODYTRODE
K961288 · Marquette Electronics, Inc. · Aug 1996
CONMED ECG/EKG ELECTRODES
K954389 · Conmedcorp · May 1996
CONMED EKG STRIPPER
K960264 · Conmedcorp · Apr 1996