Cleared Traditional

K812539 - PRE-BYPASS FILTER

K812539 is an FDA 510(k) clearance for PRE-BYPASS FILTER, manufactured by Gelman Sciences, Inc.. The device is a Class 2 Cardiovascular device with product code KRJ cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K812539 · Gelman Sciences, Inc. · Cardiovascular device
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Oct 1981
Decision
40d
Days
Class 2
Risk

K812539 is an FDA 510(k) clearance for the PRE-BYPASS FILTER. Classified as Filter, Prebypass, Cardiopulmonary Bypass (product code KRJ), Class II - Special Controls.

Submitted by Gelman Sciences, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 13, 1981 after a review of 40 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 Gelman Sciences, Inc. devices

FDA 510(k) Submission Details - K812539

510(k) Number K812539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1981
Decision Date October 13, 1981
Days to Decision 40 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
85d faster than avg
Panel avg: 125d · This submission: 40d
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 17
Devices cleared under the same product code (KRJ) and FDA review panel - the closest regulatory comparables to K812539.
SHILEY PREBYPASS FILTER
K840450 · Shiley, Inc. · Apr 1984
PRE-BYPASS FILTER #EC-PBF SERIES
K832594 · Gish Biomedical, Inc. · Sep 1983
ULTIPORE PREBYPASS PLUS FILTER
K831286 · Pall Biomedical Products Co. · Jun 1983
INTERFACE PRE BYPASS PRIME FILTER
K812240 · Medical, Inc. · Aug 1981
INTERFACE PRE BYPASS PRIME FILTER #90
K812244 · Medical, Inc. · Aug 1981
PRE-BYPASS FILTER
K810395 · Texas Medical Products, Inc. · Mar 1981