Cleared Traditional

K862455 - MODIFIED CARDIOCAP MONITOR

K862455 is an FDA 510(k) clearance for MODIFIED CARDIOCAP MONITOR, manufactured by Datex Division Instrumentarium Corp.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K862455

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
Combination Product No
PCCP Authorized No
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.

DSK Device Classification - Class 2, Special Controls

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 48
Devices cleared under the same product code (DSK) and FDA review panel - the closest regulatory comparables to K862455.
MODIFIED MODEL UA-731 DIGITAL SPHYGMOMANOMETER
K871720 · A&D Engineering, Inc. · Jul 1987
MODIFIED MODEL UA-711 DIGITAL SPHYGMONOMETER
K871718 · A&D Engineering, Inc. · Jun 1987
SIRECUST 888/888R NON-INVASIVE BLOOD PRESS MONITOR
K863042 · Siemens Medical Solutions USA, Inc. · Jan 1987
PHYSIOLOGICAL MONITOR, MODELS 401,402 & 403
K862647 · Ivy Biomedical Systems, Inc. · Aug 1986
SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE
K860689 · Spacelabs, Inc. · Jul 1986
HORIZON 2000 PHYSIOLOGICAL PATIENT MONITOR
K850879 · Mennen Medical, Inc. · Apr 1985