Cleared Traditional

K844744 - CARDIO IV/GXT STRESS TESTING SYSTEM

K844744 is the FDA 510(k) clearance for CARDIO IV/GXT STRESS TESTING SYSTEM by Intl. Medical, Inc.. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K844744 · Intl. Medical, Inc. · Cardiovascular device
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Jan 1985
Decision
49d
Days
Class 2
Risk

K844744 is an FDA 510(k) clearance for the CARDIO IV/GXT STRESS TESTING SYSTEM. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Intl. Medical, Inc. (Englewood, US). The FDA issued a Cleared decision on January 23, 1985 after a review of 49 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 Intl. Medical, Inc. devices

Submission Details

510(k) Number K844744 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1984
Decision Date January 23, 1985
Days to Decision 49 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 125d · This submission: 49d
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 162
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K844744.
CARDIOFAX ECG-6353
K860212 · Nihon Kohden America, Inc. · Apr 1986
VSM-5
K852322 · Physio-Control Corp. · Sep 1985
SURGICAL MODULE 7000 ECG
K840869 · Marquette Electronics, Inc. · Feb 1985
QUINTON 901 & 900 HOLTER SCANNER
K841611 · Quinton, Inc. · Aug 1984
VITAL SIGNS MONITOR 3
K833584 · Physio-Control Corp. · Jan 1984
CASE-II
K833458 · Marquette Electronics, Inc. · Nov 1983