Cleared Traditional

K791795 - COMP-ACT IV

K791795 is the FDA 510(k) clearance for COMP-ACT IV by Medcraft Corp.. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K791795 · Medcraft Corp. · Cardiovascular device
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Sep 1979
Decision
13d
Days
Class 2
Risk

K791795 is an FDA 510(k) clearance for the COMP-ACT IV. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Medcraft Corp. (Mchenry, US). The FDA issued a Cleared decision on September 27, 1979 after a review of 13 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 Medcraft Corp. devices

Submission Details

510(k) Number K791795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1979
Decision Date September 27, 1979
Days to Decision 13 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 125d · This submission: 13d
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 266
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K791795.
ECG MONITOR OSCILLOSCOPE MODEL OEC-3100
K800005 · Nihon Kohden America, Inc. · Mar 1980
ELECTROCARDIOGRAPH, MODEL ECG-5151
K792229 · Nihon Kohden America, Inc. · Nov 1979
MODEL 685/686 DYNAMIC ELECTROCARDI0-
K792072 · Del Mar Avionics · Nov 1979
ELECTROCARDIOGRAPH MODEL ECG-5403
K791540 · Nihon Kohden America, Inc. · Sep 1979
QUINTON MODEL 630 AND 636 ECG DATA CART
K791364 · Quinton, Inc. · Aug 1979
ECG CHANNEL OF DIAGNOSTIC SYSTEM
K791151 · Honeywell, Inc. · Jul 1979