Cleared Traditional

K931444 - PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS

K931444 is the FDA 510(k) clearance for PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS by Sorin Biomedica, Fiat, USA, Inc.. It is a Class 2 Cardiovascular device (product code DTZ) cleared through the Traditional 510(k) pathway after a 431-day FDA review.

K931444 · Sorin Biomedica, Fiat, USA, Inc. · Cardiovascular device
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May 1994
Decision
431d
Days
Class 2
Risk

K931444 is an FDA 510(k) clearance for the PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Sorin Biomedica, Fiat, USA, Inc. (Irvine, US). The FDA issued a Cleared decision on May 27, 1994 after a review of 431 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Sorin Biomedica, Fiat, USA, Inc. devices

Submission Details

510(k) Number K931444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1993
Decision Date May 27, 1994
Days to Decision 431 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
306d slower than avg
Panel avg: 125d · This submission: 431d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 120
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K931444.
MAXIMA PLUS HOLLOW FIBER OXYGENATOR
K941473 · Medtronic Vascular · Jun 1995
SARNS TURBO MEMBRANE OXYGENATOR MODIFICATION
K941653 · 3M Health Care, Sarns · Aug 1994
UNIVIX GOLD MEMBRANE OXYGENATION MODULE WITH DUROFLO II HEPARIN TREATMENT
K941225 · Baxter Healthcare Corp · Aug 1994
MINIMAX PLUS HOLLOW FIBER OXYGENATOR (WITH OR WITHOUT MEDTRONIC/CARMEDA BIOACTIVE SURFACE
K933586 · Medtronic Vascular · Feb 1994
CAPIOX SX HOLLOW FIBER OXYGENATOR
K922799 · Terumo Medical Corp. · Sep 1993
INTERSEPT FILTERED CARDIOTOMY RESERVOIR
K926226 · Medtronic Vascular · Jun 1993