Cleared Traditional

K842339 - COMPUSTRESS STRESS TESTING SYS

K842339 is the FDA 510(k) clearance for COMPUSTRESS STRESS TESTING SYS by Intl. Medical, Inc.. It is a Class 2 Cardiovascular device (product code DQK) cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K842339 · Intl. Medical, Inc. · Cardiovascular device
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Dec 1984
Decision
189d
Days
Class 2
Risk

K842339 is an FDA 510(k) clearance for the COMPUSTRESS STRESS TESTING SYS. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Intl. Medical, Inc. (Englewood, US). The FDA issued a Cleared decision on December 19, 1984 after a review of 189 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - 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 Intl. Medical, Inc. devices

Submission Details

510(k) Number K842339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1984
Decision Date December 19, 1984
Days to Decision 189 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 125d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
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 - DQK Computer, Diagnostic, Programmable

All 230
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K842339.
QUINTON Q.CATH
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Q3000
K834567 · Quinton, Inc. · Apr 1984
PDS CARDIAC CALC. SOFTW. PROGR. #A3604AE
K810750 · General Electric Co. · Mar 1981
QUINTON STATUS 1000
K782072 · Quinton, Inc. · Feb 1979