# K030264: Quandrox Safeline Hollow Fiber Membrane Oxygenator, Model Hmo 2030

- Pathway: 510(k) (Special)
- Applicant: Jostra AG
- Decided: Feb 26, 2003 after 30 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: 2 generations back to K932252 (1993). 2 ancestors in all.
43 later devices descend from it; 3 cite it directly.
4 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992559: Hollow Fiber Membrane Oygenator Quadrox Hmo 1010, Jostra Bentley (1999) Summary page 1.

## Most influential descendants
- K061628: Jostra Quadrox D Safeline Diffusion Membrane Oxygenator, Model Hmod 2030 (2006), 29 descendants of its own
- K071774: Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating, Model BE-Hmod 2000, Beq-Hmod 2030 (2008), 22 descendants of its own
- K082117: Quadrox-I Adult with and Without Integrated Arterial Filter with Softline Coating, Model# Hmo 70000, Hmo 71000 (2009), 21 descendants of its own
- 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

## Indications for use
The Hollow Fiber Membrane Oxygenator Quadrox Safeline is intended for use in an extracorporeal perfusion circuit to oxygenate blood and remove carbondioxide during short duration cardiopulmonary bypass procedures lasting 6 hours or less.

Source page: https://510kreport.com/device/K030264
Methodology: https://510kreport.com/methodology