# K102464: Quadrox-I Neonatal Microporous Membrane Oxygenator with Integrated Arterial Filter with Softline/Bioline Coating

- Pathway: 510(k) (Traditional)
- Applicant: Maquet Cardiopulmonary, AG
- Decided: Mar 4, 2011 after 189 days
- Product code: DTZ (Oxygenator, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4350
- Recalls of this device: 5 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K842908 (1985). 4 ancestors in all.
6 later devices descend from it; 2 cite it directly.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022115: Capiox RX05 Hollow Fiber Oxygenator W/Without Hardshell Reservoir, Terumo Corp. (2002)
- K943917: Capiox Arterial Filter, Terumo Medical Corp. (1995) Summary page 1.

## Most influential descendants
- K132829: Quadrox-I, Quadrox-ID, Quadrox-IR Oxygenators (2013), 4 descendants of its own
- 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
- May 18, 2023 · Class II · Z-1640-2023: 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
- May 18, 2023 · Class II · Z-1660-2023: Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, 
- Oct 25, 2018 · Class I · Z-0436-2019: There is a potential for blood leakage at the blood inlet connector when using the reducing screw adapter 1/4 x 3/16 that may result in clinically relevant loss of prime before patient connection or b
- Oct 25, 2018 · Class I · Z-0437-2019: There is a potential for blood leakage at the blood inlet connector when using the reducing screw adapter 1/4 x 3/16 that may result in clinically relevant loss of prime before patient connection or b
- 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 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 l/min and is intended for the treatment of pediatric (neonate and infant) 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.

Source page: https://510kreport.com/device/K102464
Methodology: https://510kreport.com/methodology