Cleared Traditional

K884640 - CARDIOPLEGIA OVERPRESSURE VALVE CPOP-35...

K884640 is the FDA 510(k) clearance for CARDIOPLEGIA OVERPRESSURE VALVE CPOP-35... by American Omni Medical, Inc.. It is a Class 1 Cardiovascular device (product code KRI) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K884640 · American Omni Medical, Inc. · Cardiovascular device
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Jan 1989
Decision
78d
Days
Class 1
Risk

K884640 is an FDA 510(k) clearance for the CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700. Classified as Accessory Equipment, Cardiopulmonary Bypass (product code KRI), Class I - General Controls.

Submitted by American Omni Medical, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on January 24, 1989 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4200 - 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 American Omni Medical, Inc. devices

Submission Details

510(k) Number K884640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1988
Decision Date January 24, 1989
Days to Decision 78 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 125d · This submission: 78d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KRI Accessory Equipment, Cardiopulmonary Bypass
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.4200
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.

Regulatory Peers - KRI Accessory Equipment, Cardiopulmonary Bypass

All 11
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