# K103191: Quadrox-I Pediatric Microporous Membrane Oxygenator with Integrated Arterial Filter with Softline / Bioline Coating

- Pathway: 510(k) (Traditional)
- Applicant: Maquet Cardiopulmonary, AG
- Decided: Mar 8, 2011 after 131 days
- Product code: DTZ (Oxygenator, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4350
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K991737 (2000). 7 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072091: D101 Kids Infant Hollow Fiber Membrane Oxygenator with Integrated Hardshell Cardiotomy/Venous Reservoir, Sorin Group Italia S.R.L. (2007) Summary page 1.
- 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-1655-2023: 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, 
- May 18, 2023 · Class II · Z-1641-2023: 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
- 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 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.

Source page: https://510kreport.com/device/K103191
Methodology: https://510kreport.com/methodology