Cleared Special

K093522 - QUADROX-I SMALL ADULT MICROPOROUS MEMBR...

Also marketed or referenced as:
W/ BIOLINE COATING AND W/ INTEGRATED ARTERIAL FILTER W/ BIOLINE C

K093522 is the FDA 510(k) clearance for QUADROX-I SMALL ADULT MICROPOROUS MEMBR... by Maquet Cardiopulmonary, AG. It is a Class 2 Cardiovascular device (product code DTZ) cleared through the Special 510(k) pathway after a 24-day FDA review.

K093522 · Maquet Cardiopulmonary, AG · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
24d
Days
Class 2
Risk

K093522 is an FDA 510(k) clearance for the QUADROX-I SMALL ADULT MICROPOROUS MEMBRANE OXYGENATOR. 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 December 7, 2009 after a review of 24 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. 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 K093522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2009
Decision Date December 07, 2009
Days to Decision 24 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
101d faster than avg
Panel avg: 125d · This submission: 24d
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 K093522.
QUADROX-I NEONATAL MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE/BIOLINE COATING
K102464 · Maquet Cardiopulmonary, AG · Mar 2011
QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR WITH SOFTLINE COATING, MODEL: BE-HMOD 70000-USA, BEQ-HMOD 70000-USA, HMOD
K101153 · Maquet Cardiopulmonary, AG · Dec 2010
QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODELS BE-HMOD 30000-USA, BEQ-HMOD 30000-USA
K100278 · Maquet Cardiopulmonary, AG · Apr 2010
QUADROX-I SMALL ADULT WITH AND WITHOUT INTERGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODELS HMO 50000, HMO 51000
K090689 · Maquet Cardiopulmonary, AG · Oct 2009
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