Cleared Traditional

CARDIO PERFECT, CARDIO PERFECT MD (K913374) - FDA 510(k) Clearance

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

K913374 · Cardio Control BV · Cardiovascular device
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Jan 1992
Decision
178d
Days
Class 2
Risk

K913374 is an FDA 510(k) clearance for the CARDIO PERFECT, CARDIO PERFECT MD. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Cardio Control BV (The Netherlands, NL). The FDA issued a Cleared decision on January 23, 1992 after a review of 178 days - an extended review 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: 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 Cardio Control BV devices

Submission Details

510(k) Number K913374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1991
Decision Date January 23, 1992
Days to Decision 178 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
53d slower than avg
Panel avg: 125d · This submission: 178d
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 119
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K913374.
HEWLETT-PACKARD MODEL M1264B CATHSTATION
K952173 · Hewlett-Packard Co. · Aug 1995
QUINTON MODEL 710 STRESS ELECTROCARDIOGRAPH
K945626 · Quinton, Inc. · Jun 1995
HP M1175A, M1176A, COMPONENT MONITORING SYSTEM
K941811 · Hewlett-Packard Co. · May 1994
MEDTRONIC MODEL 9455 TELETRACE III ECG MONIT SYST
K914974 · Medtronic Vascular · Dec 1991
Q4500 STREE TEST MONITOR
K910017 · Quinton, Inc. · Nov 1991
CARDIOFAX ECG-8830A
K904758 · Nihon Kohden America, Inc. · Dec 1990