Cleared Traditional

K903555 - ELECTROTRACE DISPOSABLE AG/AGCL EKG MON. ELEC.

K903555 is an FDA 510(k) clearance for ELECTROTRACE DISPOSABLE AG/AGCL EKG MON..., 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 90-day FDA review.

K903555 · Jason Marketing Co. · Cardiovascular device
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Nov 1990
Decision
90d
Days
Class 2
Risk

K903555 is an FDA 510(k) clearance for the ELECTROTRACE DISPOSABLE AG/AGCL EKG MON. ELEC.. 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 November 5, 1990 after a review of 90 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 Jason Marketing Co. devices

FDA 510(k) Submission Details - K903555

510(k) Number K903555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1990
Decision Date November 05, 1990
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
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
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