Cleared Traditional

MICRO MED INC. QRS-CARD(TM) OFFICE ECG MONITOR (K914762) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K914762 · Micromed · Cardiovascular device
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Dec 1991
Decision
44d
Days
Class 2
Risk

K914762 is an FDA 510(k) clearance for the MICRO MED INC. QRS-CARD(TM) OFFICE ECG MONITOR. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Micromed (Philadelphia, US). The FDA issued a Cleared decision on December 5, 1991 after a review of 44 days - a notably fast clearance cycle.

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: 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 Micromed devices

Submission Details

510(k) Number K914762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1991
Decision Date December 05, 1991
Days to Decision 44 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
81d faster than avg
Panel avg: 125d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 122
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K914762.
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MEDTRONIC MODEL 9455 TELETRACE III ECG MONIT SYST
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Q4500 STREE TEST MONITOR
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CARDIOFAX ECG-8830A
K904758 · Nihon Kohden America, Inc. · Dec 1990
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K900272 · Nihon Kohden America, Inc. · Jan 1990