Cleared Traditional

K902492 - CARDIOCAP II MONITORS: CH, CH-2, CH-S, CH-2S (FDA 510(k) Clearance)

Class I Cardiovascular device.

K902492 · Datex Division Instrumentarium Corp. · Cardiovascular device
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Jul 1990
Decision
31d
Days
Class 1
Risk

K902492 is an FDA 510(k) clearance for the CARDIOCAP II MONITORS: CH, CH-2, CH-S, CH-2S. Classified as Monitor, Line Isolation (product code DRI), Class I - General Controls.

Submitted by Datex Division Instrumentarium Corp. (Helsinki, Finland, FI). The FDA issued a Cleared decision on July 6, 1990 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2620 - 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 K902492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1990
Decision Date July 06, 1990
Days to Decision 31 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 125d · This submission: 31d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DRI Monitor, Line Isolation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.2620
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.