Cleared Traditional

K884640 - CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700

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

K884640 · American Omni Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K884640

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 125d · This submission: 78d
Pathway characteristics
Predicate-based equivalence.

KRI Device Classification - Class 1, General Controls

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 30
Devices cleared under the same product code (KRI) and FDA review panel - the closest regulatory comparables to K884640.
CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25
K884893 · American Omni Medical, Inc. · Jan 1989
HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR
K874605 · Mallinckrodt Critical Care · Feb 1988
CPE 2000 CARDIO PULMONARY ERGOMETER
K874925 · Medical Graphics Corp. · Jan 1988
STOCKERT-SHILEY CAPS VENOUS OCCLUSION CLAMP
K864890 · Shiley, Inc. · Feb 1987
STOCKERT-SHILEY CAPS 4 CHANNEL TEMP. MONITOR 1
K862510 · Shiley, Inc. · Jul 1986
ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE
K862549 · American Bentley · Jul 1986