Cleared Traditional

K884955 - CARDIOCAP(TM) CM-104 MONITOR

K884955 is the FDA 510(k) clearance for CARDIOCAP(TM) CM-104 MONITOR by Datex Division Instrumentarium Corp.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K884955 · Datex Division Instrumentarium Corp. · Cardiovascular device
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Dec 1988
Decision
29d
Days
Class 2
Risk

K884955 is an FDA 510(k) clearance for the CARDIOCAP(TM) CM-104 MONITOR. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Datex Division Instrumentarium Corp. (Helsinki, Finland, FI). The FDA issued a Cleared decision on December 28, 1988 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - 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 Datex Division Instrumentarium Corp. devices

Submission Details

510(k) Number K884955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1988
Decision Date December 28, 1988
Days to Decision 29 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
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 - DXN System, Measurement, Blood-pressure, Non-invasive

All 356
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K884955.
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POCKET MANOMETER
K880599 · Abbott Laboratories · Oct 1988
OHMEDA 2350 FINAPRES(R) BLOOD PRESSURE MONITOR
K880572 · Ohmeda Medical · May 1988
MODIFIED SPHYGMOMED NON-INVASIVE BLOOD PRES. MONIT
K871886 · Draeger Medical, Inc. · Jul 1987