Cleared Traditional

K810395 - PRE-BYPASS FILTER

K810395 is the FDA 510(k) clearance for PRE-BYPASS FILTER by Texas Medical Products, Inc.. It is a Class 2 Cardiovascular device (product code KRJ) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K810395 · Texas Medical Products, Inc. · Cardiovascular device
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Mar 1981
Decision
15d
Days
Class 2
Risk

K810395 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 Texas Medical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 5, 1981 after a review of 15 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 Texas Medical Products, Inc. devices

Submission Details

510(k) Number K810395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1981
Decision Date March 05, 1981
Days to Decision 15 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 125d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Devices cleared under the same product code (KRJ) and FDA review panel - the closest regulatory comparables to K810395.
SHILEY PREBYPASS FILTER
K840450 · Shiley, Inc. · Apr 1984
PRE-BYPASS FILTER #EC-PBF SERIES
K832594 · Gish Biomedical, Inc. · Sep 1983
PRE-BYPASS FILTER
K812539 · Gelman Sciences, Inc. · Oct 1981
CARDIOPLEGIA ADMINISTRATION SYSTEM CAS
K800135 · Bentley Laboratories, Inc. · Feb 1980
RECIRCULATION FILTER MODEL RF-10
K790361 · Bentley Laboratories, Inc. · Mar 1979