Cleared Traditional

K840450 - SHILEY PREBYPASS FILTER

K840450 is an FDA 510(k) clearance for SHILEY PREBYPASS FILTER, manufactured by Shiley, Inc.. The device is a Class 2 Cardiovascular device with product code KRJ cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K840450 · Shiley, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1984
Decision
76d
Days
Class 2
Risk

K840450 is an FDA 510(k) clearance for the SHILEY PREBYPASS FILTER. Classified as Filter, Prebypass, Cardiopulmonary Bypass (product code KRJ), Class II - Special Controls.

Submitted by Shiley, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 17, 1984 after a review of 76 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 Shiley, Inc. devices

FDA 510(k) Submission Details - K840450

510(k) Number K840450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1984
Decision Date April 17, 1984
Days to Decision 76 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
49d faster than avg
Panel avg: 125d · This submission: 76d
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 K840450.
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
PRE-BYPASS FILTER #EC-PBF SERIES
K832594 · Gish Biomedical, Inc. · Sep 1983
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