Cleared Traditional

K894679 - ELECTROTRACE DISP. RESTING EKG ELECTRODES

K894679 is an FDA 510(k) clearance for ELECTROTRACE DISP. RESTING EKG ELECTRODES, manufactured by Jason Marketing Co.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K894679 · Jason Marketing Co. · Cardiovascular device
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Sep 1989
Decision
50d
Days
Class 2
Risk

K894679 is an FDA 510(k) clearance for the ELECTROTRACE DISP. RESTING EKG ELECTRODES. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Jason Marketing Co. (Huntington Beach, US). The FDA issued a Cleared decision on September 13, 1989 after a review of 50 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 Jason Marketing Co. devices

FDA 510(k) Submission Details - K894679

510(k) Number K894679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1989
Decision Date September 13, 1989
Days to Decision 50 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 125d · This submission: 50d
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 195
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K894679.
ELECTRO BLUE ECG ELECT. FOAM, SILVER/SILVER CHLO.
K894991 · Labeltape Meditect, Inc. · Oct 1989
CARE DISP. DIAG. ELECTRODES, SILVER/SILVER
K894462 · Labeltape Meditect, Inc. · Oct 1989
SELECTRODE
K894920 · S & W Medico Teknik · Oct 1989
VITATRACE
K893425 · Lectec Corp. · Jul 1989
F56 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 56MM
K884980 · S & W Medico Teknik · May 1989
BARD NEONATAL ECG MONITORING ELECTRODE
K891075 · C.R. Bard, Inc. · Mar 1989