Cleared Traditional

K940126 - AVECOR PRE-BYPASS FILTER

K940126 is an FDA 510(k) clearance for AVECOR PRE-BYPASS FILTER, manufactured by Avecor Cardiovascular, Inc.. The device is a Class 2 Cardiovascular device with product code KRJ cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K940126 · Avecor Cardiovascular, Inc. · Cardiovascular device
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Jun 1994
Decision
169d
Days
Class 2
Risk

K940126 is an FDA 510(k) clearance for the AVECOR PRE-BYPASS FILTER. Classified as Filter, Prebypass, Cardiopulmonary Bypass (product code KRJ), Class II - Special Controls.

Submitted by Avecor Cardiovascular, Inc. (Plymouth, US). The FDA issued a Cleared decision on June 28, 1994 after a review of 169 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Avecor Cardiovascular, Inc. devices

FDA 510(k) Submission Details - K940126

510(k) Number K940126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1994
Decision Date June 28, 1994
Days to Decision 169 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 125d · This submission: 169d
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 18
Devices cleared under the same product code (KRJ) and FDA review panel - the closest regulatory comparables to K940126.
POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER
K990276 · Porous Media Corp. · Oct 1999
POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER
K982385 · Porous Media Corp. · Feb 1999
PREBYPASS FILTER, CAT. NO. FPB-5
K900672 · American Omni Medical, Inc. · Apr 1990
ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE
K875094 · Pall Biomedical Products Co. · Feb 1988
PREBYPASS FILTER
K871350 · American Omni Medical, Inc. · Jun 1987
INTERFACE CRYSTALLOID CARDIOPLEGIC FILTER MODEL 70
K861226 · Medical, Inc. · Jun 1986