Cleared Traditional

K903722 - MICROMED QRS CARD

K903722 is an FDA 510(k) clearance for MICROMED QRS CARD, manufactured by Nasiff Assoc., Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K903722 · Nasiff Assoc., Inc. · Cardiovascular device
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Dec 1990
Decision
112d
Days
Class 2
Risk

K903722 is an FDA 510(k) clearance for the MICROMED QRS CARD. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Nasiff Assoc., Inc. (Brewerton, US). The FDA issued a Cleared decision on December 5, 1990 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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 Nasiff Assoc., Inc. devices

FDA 510(k) Submission Details - K903722

510(k) Number K903722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1990
Decision Date December 05, 1990
Days to Decision 112 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 125d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 342
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K903722.
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K900700 · Ppg Industries, Inc. · Apr 1990