Cleared Traditional

K932252 - AFFINITY HOLLOW FIBER OXYGENATOR

K932252 is an FDA 510(k) clearance for AFFINITY HOLLOW FIBER OXYGENATOR, manufactured by Avecor Cardiovascular, Inc.. The device is a Class 2 Cardiovascular device with product code DTZ cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K932252 · Avecor Cardiovascular, Inc. · Cardiovascular device
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Nov 1993
Decision
177d
Days
Class 2
Risk

K932252 is an FDA 510(k) clearance for the AFFINITY HOLLOW FIBER OXYGENATOR. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Avecor Cardiovascular, Inc. (Plymouth, US). The FDA issued a Cleared decision on November 19, 1993 after a review of 177 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4350 - 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 - K932252

510(k) Number K932252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1993
Decision Date November 19, 1993
Days to Decision 177 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
52d slower than avg
Panel avg: 125d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTZ Device Classification - Class 2, Special Controls

Product Code DTZ Oxygenator, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4350
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 - DTZ Oxygenator, Cardiopulmonary Bypass

All 227
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K932252.
WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR
K934292 · Minntech Corp. · Jul 1994
PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS
K931444 · Sorin Biomedica, Fiat, USA, Inc. · May 1994
MINIMAX PLUS HOLLOW FIBER OXYGENATOR (WITH OR WITHOUT MEDTRONIC/CARMEDA BIOACTIVE SURFACE
K933586 · Medtronic Vascular · Feb 1994
COBE CMS-FS MEMBRANE OXYGENATOR
K926467 · Cobe Cardiovascular, Inc. · Nov 1993
CAPIOX SX HOLLOW FIBER OXYGENATOR
K922799 · Terumo Medical Corp. · Sep 1993
INTERSEPT FILTERED CARDIOTOMY RESERVOIR
K926226 · Medtronic Vascular · Jun 1993