Cleared Traditional

DURAFLO II HEPARIN OXYGENATOR MODEL UNIVOX GOLD (K910107) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K910107 · Baxter Healthcare Corp · Cardiovascular device
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Apr 1991
Decision
90d
Days
Class 2
Risk

K910107 is an FDA 510(k) clearance for the DURAFLO II HEPARIN OXYGENATOR MODEL UNIVOX GOLD. 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 April 10, 1991 after a review of 90 days - within the typical 510(k) review window.

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 K910107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1991
Decision Date April 10, 1991
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
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 81
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K910107.
MINIMAX(R)/MAXIMA(R) HOLLOW FIBER OXYGENATORS
K920889 · Medtronic Vascular · Sep 1992
MINIMAX OXYGENATION SYSTEM
K912655 · Medtronic Vascular · Sep 1991
MEDTRONIC MINIMAX HOLLOW FIBER OXYGENATOR
K897068 · Medtronic Vascular · Aug 1991
SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY.
K901624 · Shiley, Inc. · Jul 1990
PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR
K901249 · Shiley, Inc. · Jun 1990
PLEXUS 2(TM) INFANT HOLLOW FIBER OXYGENATOR
K901250 · Shiley, Inc. · Jun 1990