Cleared Traditional

OXYGENATOR GAS LINE FILTER (K792151) - FDA 510(k) Clearance

Class I Cardiovascular device.

K792151 · Cardio Systems, Inc. · Cardiovascular device
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Nov 1979
Decision
22d
Days
Class 1
Risk

K792151 is an FDA 510(k) clearance for the OXYGENATOR GAS LINE FILTER. Classified as Accessory Equipment, Cardiopulmonary Bypass (product code KRI), Class I - General Controls.

Submitted by Cardio Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 13, 1979 after a review of 22 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 Cardio Systems, Inc. devices

Submission Details

510(k) Number K792151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1979
Decision Date November 13, 1979
Days to Decision 22 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 125d · This submission: 22d
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 9
Devices cleared under the same product code (KRI) and FDA review panel - the closest regulatory comparables to K792151.
SHILEY GAS FILTER
K832704 · Shiley, Inc. · Sep 1983
TMO INTEGRATED CIRCUIT SYSTEM
K820406 · Travenol Laboratories, S.A. · Mar 1982
WILLIAM HARVEY OXYGENATING GAS FILTER
K802906 · C.R. Bard, Inc. · Dec 1980
SHILEY QUICK DISCONNECT ASSEMBLY
K791829 · Shiley, Inc. · Oct 1979
VALVE, PRESSURE RELIEF, BLOOD OXYGENATOR
K770681 · Scimed Life Systems, Inc. · Apr 1977