# K133265: Quadrox-IR Adult and Small Adult

- Pathway: 510(k) (Special)
- Applicant: Maquet Cardiopulmonary, AG
- Decided: Nov 12, 2013 after 20 days
- Product code: KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type)
- Device class: 2
- Regulation: 21 CFR 870.4360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K922933 (1992). 111 ancestors in all.
No later device cites it as a predicate yet.
3 of 112 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102726: Cardiohelp System, Maquet Cardiopulmonary, AG (2011) Summary page 2.
- K132829: Quadrox-I, Quadrox-ID, Quadrox-IR Oxygenators, Maquet Cardiopulmonary, AG (2013) Summary page 2.

## Indications for use
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).

Source page: https://510kreport.com/device/K133265
Methodology: https://510kreport.com/methodology