Cleared Traditional

K941225 - UNIVIX GOLD MEMBRANE OXYGENATION MODULE WITH DUROFLO II HEPARIN TREATMENT

K941225 is an FDA 510(k) clearance for UNIVIX GOLD MEMBRANE OXYGENATION MODULE..., manufactured by Baxter Healthcare Corp. The device is a Class 2 Cardiovascular device with product code DTZ cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K941225 · Baxter Healthcare Corp · Cardiovascular device
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Aug 1994
Decision
155d
Days
Class 2
Risk

K941225 is an FDA 510(k) clearance for the UNIVIX GOLD MEMBRANE OXYGENATION MODULE WITH DUROFLO II HEPARIN TREATMENT. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Irvine, US). The FDA issued a Cleared decision on August 16, 1994 after a review of 155 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 Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K941225

510(k) Number K941225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1994
Decision Date August 16, 1994
Days to Decision 155 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 125d · This submission: 155d
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 236
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K941225.
SPIRALGOLD & SPIRALOXY HOLLOW FIBER OXYGENATORS
K951247 · Baxter Healthcare Corp · Nov 1995
MAXIMA PLUS HOLLOW FIBER OXYGENATOR
K941473 · Medtronic Vascular · Jun 1995
SARNS TURBO MEMBRANE OXYGENATOR MODIFICATION
K941653 · 3M Health Care, Sarns · Aug 1994
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