Cleared Special

K132829 - QUADROX-I

K132829 is the FDA 510(k) clearance for QUADROX-I by Maquet Cardiopulmonary, AG. It is a Class 2 Cardiovascular device (product code DTZ) cleared through the Special 510(k) pathway after a 29-day FDA review.

K132829 · Maquet Cardiopulmonary, AG · Cardiovascular device
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Oct 2013
Decision
29d
Days
Class 2
Risk

K132829 is an FDA 510(k) clearance for the QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Maquet Cardiopulmonary, AG (Wayne, US). The FDA issued a Cleared decision on October 8, 2013 after a review of 29 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 K132829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2013
Decision Date October 08, 2013
Days to Decision 29 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
96d faster than avg
Panel avg: 125d · This submission: 29d
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 K132829.
QUADROX-i Adult/Small Adult Oxygenators
K150267 · Maquet Cardiopulmonary, AG · May 2015
Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Carmeda Biosurface
K143073 · Medtronic, Inc. · Mar 2015
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface
K142784 · Medtronic, Inc. · Oct 2014
INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR, INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATE
K130433 · Sorin Group Italia S.R.L. · Mar 2013
CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR
K130333 · Terumo Cardiovascular Systems Corp. · Mar 2013
CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OXGENATOR WITH DETACHA
K130359 · Terumo Cardiovascular Systems Corp. · Mar 2013