Cleared Traditional

K790544 - STRESS TESTING SYSTEM, MULTI-POSITION

K790544 is an FDA 510(k) clearance for STRESS TESTING SYSTEM, manufactured by Engineering Dynamics Corp.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K790544 · Engineering Dynamics Corp. · Cardiovascular device
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Jun 1979
Decision
75d
Days
Class 2
Risk

K790544 is an FDA 510(k) clearance for the STRESS TESTING SYSTEM, MULTI-POSITION. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Engineering Dynamics Corp. (Mchenry, US). The FDA issued a Cleared decision on June 5, 1979 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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 Engineering Dynamics Corp. devices

FDA 510(k) Submission Details - K790544

510(k) Number K790544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1979
Decision Date June 05, 1979
Days to Decision 75 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 125d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRT Device Classification - Class 2, Special Controls

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 221
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K790544.
A-V MINI CLINIC
K800405 · Instromedix, Inc. · Jul 1980
HEART RATE MONITOR MD-1
K792312 · Medical Devices, Inc. · Nov 1979
AIR-SHIELDS HEART RATE MONITOR
K792117 · Narco Air-Shields · Nov 1979
AS7 & AS8 MONITORS
K790552 · Narco Air-Shields · May 1979
MODEL 78801A PATIENT MONITORS
K790454 · Hewlett-Packard Co. · Apr 1979
MONITOR, ELECTROCARDIOSCOPE
K790292 · Burdick Corp. · Feb 1979