Cleared Traditional

K862455 - MODIFIED CARDIOCAP MONITOR

K862455 is the FDA 510(k) clearance for MODIFIED CARDIOCAP MONITOR by Datex Division Instrumentarium Corp.. It is a Class 2 Cardiovascular device (product code DSK) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K862455 · Datex Division Instrumentarium Corp. · Cardiovascular device
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Sep 1986
Decision
89d
Days
Class 2
Risk

K862455 is an FDA 510(k) clearance for the MODIFIED CARDIOCAP MONITOR. Classified as Computer, Blood-pressure (product code DSK), Class II - Special Controls.

Submitted by Datex Division Instrumentarium Corp. (Wilmington, US). The FDA issued a Cleared decision on September 24, 1986 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1110 - 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 K862455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1986
Decision Date September 24, 1986
Days to Decision 89 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 125d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSK Computer, Blood-pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1110
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 - DSK Computer, Blood-pressure

All 9
Devices cleared under the same product code (DSK) and FDA review panel - the closest regulatory comparables to K862455.
Endophys Blood Pressure Monitor model BPM-30
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K863042 · Siemens Medical Solutions USA, Inc. · Jan 1987
MODEL 78553A PRESSURE PLUG-IN MODULE
K822878 · Hewlett-Packard Co. · Oct 1982
MODEL 1100 SPHYGMOMANOMETER
K811208 · Y · May 1981
MONITOR, PRESSURVEIL
K790135 · Concept, Inc. · Feb 1979