# K150267: QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators

- Pathway: 510(k) (Traditional)
- Applicant: Maquet Cardiopulmonary, AG
- Decided: May 7, 2015 after 92 days
- Product code: DTZ (Oxygenator, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4350
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K922933 (1992). 43 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 46 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132829: Quadrox-I, Quadrox-ID, Quadrox-IR Oxygenators, Maquet Cardiopulmonary, AG (2013) Summary page 7.

## Most influential descendants
- 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

## Recalls of this device
- May 18, 2023 · Class II · Z-1636-2023: 1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both i
- Feb 23, 2016 · Class II · Z-1371-2016: Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.

## Indications for use
The membrane oxygenator QUADROX-i Adult is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 – 7 l/min. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide from the blood 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 µm. 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 use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 – 5 l/min. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide from the blood 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 µm. 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-iD Adult is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 - 7 l/min. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide from the blood and regulates the blood temperature. The device’s utilization period is limited to six hours. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.

Source page: https://510kreport.com/device/K150267
Methodology: https://510kreport.com/methodology