Cleared Traditional

K896190 - CARDIOCAP(TM) CMX-104 MONITOR

K896190 is the FDA 510(k) clearance for CARDIOCAP(TM) CMX-104 MONITOR by Datex Division Instrumentarium Corp.. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K896190 · Datex Division Instrumentarium Corp. · Cardiovascular device
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Mar 1990
Decision
133d
Days
Class 2
Risk

K896190 is an FDA 510(k) clearance for the CARDIOCAP(TM) CMX-104 MONITOR. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Datex Division Instrumentarium Corp. (Helsinki, Finland, FI). The FDA issued a Cleared decision on March 8, 1990 after a review of 133 days - within the typical 510(k) review window.

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 Datex Division Instrumentarium Corp. devices

Submission Details

510(k) Number K896190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1989
Decision Date March 08, 1990
Days to Decision 133 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 125d · This submission: 133d
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 K896190.
Q4500 STREE TEST MONITOR
K910017 · Quinton, Inc. · Nov 1991
CARDIOFAX ECG-8830A
K904758 · Nihon Kohden America, Inc. · Dec 1990
TRAMSCOPE SYSTEM
K900598 · Marquette Electronics, Inc. · Apr 1990
NKA MODELS AB-601G AND AB-621G
K900272 · Nihon Kohden America, Inc. · Jan 1990
7610 COLORVIEW SLAVE SCOPE
K890481 · Marquette Electronics, Inc. · Mar 1989
EXCALIBUR CONTROLLER (WORK LOAD PROGRAMMER)
K883402 · Quinton, Inc. · Jan 1989