# K992559: Hollow Fiber Membrane Oygenator Quadrox Hmo 1010

- Pathway: 510(k) (Traditional)
- Applicant: Jostra Bentley
- Decided: Sep 20, 1999 after 52 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: 1 generation back to K932252 (1993). 1 ancestor in all.
45 later devices descend from it; 4 cite it directly.
4 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932252: Affinity Hollow Fiber Oxygenator, Avecor Cardiovascular, Inc. (1993) Summary page 1.

## Most influential descendants
- K030264: Quandrox Safeline Hollow Fiber Membrane Oxygenator, Model Hmo 2030 (2003), 43 descendants of its own
- 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

## Indications for use
The Hollow Fibre Membrane Oxygenator HMO 1010 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/K992559
Methodology: https://510kreport.com/methodology