Cleared Traditional

K964213 - TRACE RITE SOLID GEL ECG ELECTRODES

K964213 is an FDA 510(k) clearance for TRACE RITE SOLID GEL ECG ELECTRODES, manufactured by Bio-Detek, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K964213

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
Combination Product No
PCCP Authorized No
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.

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 153
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K964213.
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