Cleared Traditional

K890504 - CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAI...

K890504 is an FDA 510(k) clearance for CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAI..., manufactured by Gish Biomedical, Inc.. The device is a Class 2 Cardiovascular device with product code JOD cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K890504 · Gish Biomedical, Inc. · Cardiovascular device
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Mar 1989
Decision
37d
Days
Class 2
Risk

K890504 is an FDA 510(k) clearance for the CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAINAGE VENOUS. Classified as Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass (product code JOD), Class II - Special Controls.

Submitted by Gish Biomedical, Inc. (Santa Ana, US). The FDA issued a Cleared decision on March 10, 1989 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4270 - 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 Gish Biomedical, Inc. devices

FDA 510(k) Submission Details - K890504

510(k) Number K890504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1989
Decision Date March 10, 1989
Days to Decision 37 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
88d faster than avg
Panel avg: 125d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOD Device Classification - Class 2, Special Controls

Product Code JOD Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4270
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 - JOD Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass

Devices cleared under the same product code (JOD) and FDA review panel - the closest regulatory comparables to K890504.
PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANE
K875095 · Pall Biomedical Products Co. · Feb 1988
PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE
K874405 · Pall Biomedical Products Co. · Dec 1987
SWANK CARDIOTOMY SUCTION LINE BLOOD FILTER CA100
K855067 · Cobe Laboratories, Inc. · Feb 1986
CARDIOTOMY FILTER
K830634 · Texas Medical Products, Inc. · Jun 1983
EXTRACORPEAL CARDIOTOMY BLOOD FILTER
K780653 · Cobe Laboratories, Inc. · Jun 1978