# K132829: Quadrox-I, Quadrox-ID, Quadrox-IR Oxygenators - Pathway: 510(k) (Special) - Applicant: Maquet Cardiopulmonary, AG - Decided: Oct 8, 2013 after 29 days - Product code: DTZ (Oxygenator, Cardiopulmonary Bypass) - Device class: 2 - Regulation: 21 CFR 870.4350 - Recalls of this device: 1 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 9 generations back to K922933 (1992). 42 ancestors in all. 4 later devices descend from it; 2 cite it directly. 1 of 47 devices in its family (counting itself) has a Class I recall. ## Predicates on the family tree (from the FDA summary) - K082117: Quadrox-I Adult with and Without Integrated Arterial Filter with Softline Coating, Model# Hmo 70000, Hmo 71000, Maquet Cardiopulmonary, AG (2009) Summary page 2. - K090511: Quadrox-I Adult Microporous Membrane Oxygenator with Bioline Coating, Model BEHMO70000,Beq-HMO70000, Maquet Cardiopulmonary, AG (2009) - K090689: Quadrox-I Small Adult with and Without Intergrated Arterial Filter with Softline Coating, Models Hmo 50000, Hmo 51000, Maquet Cardiopulmonary, AG (2009) Summary page 2. - K093522: Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline Coating and W/ Integrated Arterial Filter W/ Bioline C, Maquet Cardiopulmonary, AG (2009) Summary page 2. - K103191: Quadrox-I Pediatric Microporous Membrane Oxygenator with Integrated Arterial Filter with Softline / Bioline Coating, Maquet Cardiopulmonary, AG (2011) Summary page 2. - K102464: Quadrox-I Neonatal Microporous Membrane Oxygenator with Integrated Arterial Filter with Softline/Bioline Coating, Maquet Cardiopulmonary, AG (2011) Summary page 2. - K101153: Quadrox-ID Adult Diffusion Membrane Oxygenator with Softline Coating, Model: BE-Hmod 70000-Usa, Beq-Hmod 70000-Usa, Hmod, Maquet Cardiopulmonary, AG (2010) Summary page 2. - K100278: Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Models BE-Hmod 30000-Usa, Beq-Hmod 30000-Usa, Maquet Cardiopulmonary, AG (2010) Summary page 2. ## Most influential descendants - K150267: QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators (2015), 2 descendants of its own - K203424: Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E2 (2021), 1 descendant of its own - K240934: Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3); (2026), 0 descendants of its own - K133265: Quadrox-IR Adult and Small Adult (2013), 0 descendants of its own ## Recalls of this device - Mar 5, 2015 · Class II · Z-1689-2015: A potential issue was detected that could result in blood leakage from the gas outlet port in all lots of Quadrox-iD Adult Diffusion Membrane Oxygenator with Bioline and Softline Coatings, Custom Tubi ## Indications for use The membrane oxygenator Ouadrox-i Adult is intended for the use In extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates the blood, eliminates carton dioxide and regulates blood temperature. The Quadrox-i Adult (HMO 71000) version with integrated arterial filter also filters out air bubbles and particles larger than 40 Pm. The device's utilization period is limited to six hours. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician The membrane oxygenator QUADROX-l Small Adult is Intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 - 5 1/mm. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and regulates blood temperature. The QUADROX-i Small Adult (HMO 51000) version with integrated arterial filter also filters out air bubbles and particles larger than 40 pm. The device's utilization period is limbted to six hours. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician. The membrane oxygenator QUADROX-i Pediatric is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. It is designed for a blood flow rate of 0.2 - 2.8 I/min and is intended for the treatment of pediatric patients. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide and regulates the blood temperature. The QUADROX-i Pediatric (HMO 31000) model with integrated arterial fihter also filters air bubbles and particles larger than 33 pm. The utilization period of this device is restricted to six hours. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician. The membrane oxygenator QUADROX-i Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. It is designed for a blood flow rate of 0.2 - '1.5 11mm and is intended for the treatment of pediatric patients. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide and regulates the blood temperature. The QUADROX-i Neonatal (HMO 11000) model with integrated arterial filter also filters air bubbles and particles larger than 33 pm. The utilization period of this device is restricted to six hours. Responsibility for deciding whether to use an oxygenator rests solely with the. attending physician. The QUADROX-iD Adult Diffusion Membrane Oxygenator is intended for use in an extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide from the blood and regulates the blood temperature. The application duration is limited to 6 hours. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician. The Diffusion Membrane Oxygenator QUADROX-iD) Pediatric is intended for use in an extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The oxygenator is designed far a blood flow rate of 0.2 - 2.8 1/min and is intended for the treatment of pediatric patients. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide and regulates the blood temperature. The utilization period for this device is restricted to six hours. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician. Source page: https://510kreport.com/device/K132829 Methodology: https://510kreport.com/methodology