Cleared Traditional

K832594 - PRE-BYPASS FILTER #EC-PBF SERIES

K832594 is an FDA 510(k) clearance for PRE-BYPASS FILTER #EC-PBF SERIES, manufactured by Gish Biomedical, Inc.. The device is a Class 2 Cardiovascular device with product code KRJ cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K832594 · Gish Biomedical, Inc. · Cardiovascular device
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Sep 1983
Decision
49d
Days
Class 2
Risk

K832594 is an FDA 510(k) clearance for the PRE-BYPASS FILTER #EC-PBF SERIES. Classified as Filter, Prebypass, Cardiopulmonary Bypass (product code KRJ), Class II - Special Controls.

Submitted by Gish Biomedical, Inc. (Walker, US). The FDA issued a Cleared decision on September 20, 1983 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4280 - 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 - K832594

510(k) Number K832594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1983
Decision Date September 20, 1983
Days to Decision 49 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
76d faster than avg
Panel avg: 125d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRJ Device Classification - Class 2, Special Controls

Product Code KRJ Filter, Prebypass, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4280
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 - KRJ Filter, Prebypass, Cardiopulmonary Bypass

All 10
Devices cleared under the same product code (KRJ) and FDA review panel - the closest regulatory comparables to K832594.
ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE
K875094 · Pall Biomedical Products Co. · Feb 1988
SOLUTION CLARIFICATION UNIT
K842141 · Pall Biomedical Products Co. · Aug 1984
SHILEY PREBYPASS FILTER
K840450 · Shiley, Inc. · Apr 1984
ULTIPORE PREBYPASS PLUS FILTER
K831286 · Pall Biomedical Products Co. · Jun 1983
PRE-BYPASS FILTER
K812539 · Gelman Sciences, Inc. · Oct 1981
PRE-BYPASS FILTER
K810395 · Texas Medical Products, Inc. · Mar 1981