Cleared Special

K090511 - QUADROX-I ADULT MICROPOROUS MEMBRANE OX...

K090511 is the FDA 510(k) clearance for QUADROX-I ADULT MICROPOROUS MEMBRANE OX... by Maquet Cardiopulmonary, AG. It is a Class 2 Cardiovascular device (product code DTZ) cleared through the Special 510(k) pathway after a 106-day FDA review.

K090511 · Maquet Cardiopulmonary, AG · Cardiovascular device
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Jun 2009
Decision
106d
Days
Class 2
Risk

K090511 is an FDA 510(k) clearance for the QUADROX-I ADULT MICROPOROUS MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL B.... 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 June 12, 2009 after a review of 106 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Maquet Cardiopulmonary, AG devices

Submission Details

510(k) Number K090511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2009
Decision Date June 12, 2009
Days to Decision 106 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 125d · This submission: 106d
Pathway characteristics
Modification to existing cleared device.

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 K090511.
APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
K092895 · Sorin Group Italia S.R.L. · Oct 2009
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K090449 · Gish Biomedical, Inc. · Sep 2009
MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LT
K090450 · Gish Biomedical, Inc. · Sep 2009
MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LT
K082403 · Gish Biomedical, Inc. · May 2009
QUADROX-I ADULT WITH AND WITHOUT INTEGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODEL# HMO 70000, HMO 71000
K082117 · Maquet Cardiopulmonary, AG · Feb 2009
VISION HOLLOW FIBER OXYGENATOR WITH HA COATING
K080708 · Gish Biomedical, Inc. · Feb 2009