Cleared Traditional

K082117 - QUADROX-I ADULT WITH AND WITHOUT INTEGR...

K082117 is the FDA 510(k) clearance for QUADROX-I ADULT WITH AND WITHOUT INTEGR... by Maquet Cardiopulmonary, AG. It is a Class 2 Cardiovascular device (product code DTZ) cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K082117 · Maquet Cardiopulmonary, AG · Cardiovascular device
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Feb 2009
Decision
205d
Days
Class 2
Risk

K082117 is an FDA 510(k) clearance for the QUADROX-I ADULT WITH AND WITHOUT INTEGRATED ARTERIAL FILTER WITH SOFTLINE COA.... 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 February 18, 2009 after a review of 205 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 K082117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2008
Decision Date February 18, 2009
Days to Decision 205 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
80d slower than avg
Panel avg: 125d · This submission: 205d
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 K082117.
MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LT
K090450 · Gish Biomedical, Inc. · Sep 2009
QUADROX-I ADULT MICROPOROUS MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BEHMO70000,BEQ-HMO70000
K090511 · Maquet Cardiopulmonary, AG · Jun 2009
MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LT
K082403 · Gish Biomedical, Inc. · May 2009
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