# K112360: Quadrox-I Microporporous Membrane Oxgenator Series and Qudrox-ID Diffusion Membrane Oxygenators Series

- Pathway: 510(k) (Special)
- Applicant: Maquet Cardiopulmonary, AG
- Decided: Sep 15, 2011 after 29 days
- Product code: DTZ (Oxygenator, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4350
- Recalls of this device: 12 (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). 48 ancestors in all.
No later device cites it as a predicate yet.
1 of 49 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 1.
- K090511: Quadrox-I Adult Microporous Membrane Oxygenator with Bioline Coating, Model BEHMO70000,Beq-HMO70000, Maquet Cardiopulmonary, AG (2009) Summary page 1.
- 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 1.
- 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 1.
- K103191: Quadrox-I Pediatric Microporous Membrane Oxygenator with Integrated Arterial Filter with Softline / Bioline Coating, Maquet Cardiopulmonary, AG (2011) Summary page 1.
- K102464: Quadrox-I Neonatal Microporous Membrane Oxygenator with Integrated Arterial Filter with Softline/Bioline Coating, Maquet Cardiopulmonary, AG (2011) Summary page 1.
- 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 1.
- 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 1.
- K090555: Plegiox Cardioplegia Heat Exchanger with Softline Coating, Model Bio-CHX 30, Maquet Cardiopulmonary, AG (2009) Summary page 1.

## Cited in the summary but kept off the family tree
- K102627: QUADROX-iR Adult. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Recalls of this device
- Jan 16, 2024 · Class II · Z-1077-2024: The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection.
- Jan 16, 2024 · Class II · Z-1076-2024: The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection.
- Feb 13, 2023 · Class II · Z-1188-2023: Firm has initiated a removal of the product due to insufficient evidence of packaging sterility. Exposure to a non-sterile medical device may result in inflammation, infection, sepsis, or ischemia.
- Jul 22, 2022 · Class II · Z-1764-2022: The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6,
- Jul 22, 2022 · Class II · Z-1765-2022: The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6,
- Jul 22, 2022 · Class II · Z-1767-2022: The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6,
- Jul 22, 2022 · Class II · Z-1766-2022: The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6,
- Nov 20, 2020 · Class II · Z-0633-2021: The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier.
- Nov 20, 2020 · Class II · Z-0632-2021: The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier.
- Jul 11, 2019 · Class II · Z-2149-2019: The sets are configured with quick connectors that have been assembled in reverse on the arterial and venous lines, resulting in blue (venous) to red (arterial) and red (arterial) to blue (venous) con
- Aug 15, 2013 · Class II · Z-2262-2013: The manufacturer has conducted a review of the results of product testing performed during the last twelve months and has identified specific lots of product which may not meet specifications for bond
- Jun 12, 2012 · Class II · Z-0160-2013: It has come to firm's attention that, in some rare cases, the blood outlet connector on some models of MAQUET Oxygenators may detach from the oxygenator. This event has occurred in about 0.01% (1:10,0

## Indications for use
The membrane oxygenator Quadrox-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 carbon 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-i 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 Llmin. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and regulates blood temperature. The OUADROX-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 limited 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 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 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 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 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 for a blood flow rate of 0.2 - 2.8 1/mm 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. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours). The CARDIOHELP System in configuration with the HLS/HIT Set Advanced is intended to be used within the hospital environment and outside the hospital environment (for periods up to six hours), e.g. for intra- and inter-hospital transport. The CARDIOHELP System in configuration with the QUADROX-iR is intended to be used in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery (for periods for up to six hours). The PLEGIOX Heat Exchanger is used to set and maintain the temperature (for given flow rates and within the given temperature range) of blood cardiopiegic and crystalloid cardioplegic solutions during extracorporeal circulation. The product is designed for single use only, for an application period of no longer than 6 hours.

Source page: https://510kreport.com/device/K112360
Methodology: https://510kreport.com/methodology