Cleared Traditional

K884956 - CARDIOCAP(TM) CTO-104 MONITOR

K884956 is an FDA 510(k) clearance for CARDIOCAP(TM) CTO-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 28-day FDA review.

K884956 · Datex Division Instrumentarium Corp. · Cardiovascular device
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Dec 1988
Decision
28d
Days
Class 2
Risk

K884956 is an FDA 510(k) clearance for the CARDIOCAP(TM) CTO-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 December 27, 1988 after a review of 28 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 Datex Division Instrumentarium Corp. devices

FDA 510(k) Submission Details - K884956

510(k) Number K884956 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1988
Decision Date December 27, 1988
Days to Decision 28 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 125d · This submission: 28d
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 K884956.
EXCALIBUR CONTROLLER (WORK LOAD PROGRAMMER)
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K882254 · Nihon Kohden America, Inc. · Nov 1988
ECG MONITOR AND RESPIRATION PACER
K881055 · D. E. Hokanson, Inc. · Aug 1988