Cleared Traditional

K896190 - CARDIOCAP(TM) CMX-104 MONITOR

K896190 is an FDA 510(k) clearance for CARDIOCAP(TM) CMX-104 MONITOR, manufactured by Datex Division Instrumentarium Corp.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K896190

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
Combination Product No
PCCP Authorized No
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.

DPS Device Classification - Class 2, Special Controls

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 326
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K896190.
FUKUDA DENSHI MODEL FX-3101
K901817 · Fukuda Denshi USA, Inc. · Aug 1990
TRAMSCOPE SYSTEM
K900598 · Marquette Electronics, Inc. · Apr 1990
SMU 611 UNIVERSALMONITOR
K900700 · Ppg Industries, Inc. · Apr 1990
NKA MODELS AB-601G AND AB-621G
K900272 · Nihon Kohden America, Inc. · Jan 1990
MINIMON 7133B PATIENT MONITOR
K896386 · Kontron Instruments, Inc. · Dec 1989
KONTRON KOLORMON 7250 PATIENT MONITOR
K896417 · Kontron Instruments, Inc. · Dec 1989