Cleared Special

K090511 - QUADROX-I ADULT MICROPOROUS MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BEHMO70000,BEQ-HMO70000

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

K090511 · Maquet Cardiopulmonary, AG · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K090511

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.

DTZ Device Classification - Class 2, Special Controls

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 253
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
MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT
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
K090511 · QUADROX-I ADULT MICROPOROUS MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BEHMO70000,BEQ-HMO70000
Download PDF FDA Summary Maquet Cardiopulmonar…