# K071774: Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating, Model BE-Hmod 2000, Beq-Hmod 2030

- Pathway: 510(k) (Traditional)
- Applicant: Maquet Cardiopulmonary, AG
- Decided: Jan 23, 2008 after 208 days
- Product code: DTZ (Oxygenator, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K932252 (1993). 4 ancestors in all.
22 later devices descend from it; 5 cite it directly.
3 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061628: Jostra Quadrox D Safeline Diffusion Membrane Oxygenator, Model Hmod 2030, Maquet Cardiopulmonary, AG (2006) Summary page 1.

## Most influential descendants
- K082544: Quart Arterial Filter with Bioline Coating (2008), 13 descendants of its own
- K090511: Quadrox-I Adult Microporous Membrane Oxygenator with Bioline Coating, Model BEHMO70000,Beq-HMO70000 (2009), 12 descendants of its own
- K093522: Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline Coating and W/ Integrated Arterial Filter W/ Bioline C (2009), 8 descendants of its own
- K080592: HLM Tubing Set with Bioline Coating (2008), 8 descendants of its own
- K101153: Quadrox-ID Adult Diffusion Membrane Oxygenator with Softline Coating, Model: BE-Hmod 70000-Usa, Beq-Hmod 70000-Usa, Hmod (2010), 6 descendants of its own

## Indications for use
The Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating is used for extracorporeal circulation during cardiopulmonary bypass in the field of open-heart surgery. Within the indicated flow rates blood is oxygenated and carbon dioxide is removed. The utilization period of this device is restricted to six hours. The application and use of the oxygenator is the sole responsibility of the attending physician.

Source page: https://510kreport.com/device/K071774
Methodology: https://510kreport.com/methodology