Cleared Traditional

K941225 - UNIVIX GOLD MEMBRANE OXYGENATION MODULE...

K941225 is the FDA 510(k) clearance for UNIVIX GOLD MEMBRANE OXYGENATION MODULE... by Baxter Healthcare Corp. It is a Class 2 Cardiovascular device (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

Submission Details

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.

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 195
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
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