Cleared Traditional

K071774 - JOSTRA QUADROX D DIFFUSION MEMBRANE OXY...

K071774 is the FDA 510(k) clearance for JOSTRA QUADROX D DIFFUSION MEMBRANE OXY... by Maquet Cardiopulmonary, AG. It is a Class 2 Cardiovascular device (product code DTZ) cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K071774 · Maquet Cardiopulmonary, AG · Cardiovascular device
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Jan 2008
Decision
208d
Days
Class 2
Risk

K071774 is an FDA 510(k) clearance for the JOSTRA QUADROX D DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BE.... Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Maquet Cardiopulmonary, AG (Hirrlingen, DE). The FDA issued a Cleared decision on January 23, 2008 after a review of 208 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 Maquet Cardiopulmonary, AG devices

Submission Details

510(k) Number K071774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2007
Decision Date January 23, 2008
Days to Decision 208 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 125d · This submission: 208d
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 190
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K071774.
VISION HOLLOW FIBER OXYGENATOR WITH HA COATING
K080708 · Gish Biomedical, Inc. · Feb 2009
APEX HP M PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
K083021 · Sorin Group Italia S.R.L. · Oct 2008
SYNTHESIS PH.I.S.I.O. ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARETERIAL FILTER AND HARDSHELL VENOUS/CARIOTOMY RESERVOI
K073380 · Sorin Group Italia S.R.L. · Feb 2008
D101 KIDS INFANT HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL CARDIOTOMY/VENOUS RESERVOIR
K072091 · Sorin Group Italia S.R.L. · Oct 2007
CAPIOX RX OXYGENATOR WITH OR WITHOUT RESERVOIR
K062381 · Terumo Cardiovascular Systems Corp. · Aug 2006
JOSTRA QUADROX D SAFELINE DIFFUSION MEMBRANE OXYGENATOR, MODEL HMOD 2030
K061628 · Maquet Cardiopulmonary, AG · Aug 2006