# K932252: Affinity Hollow Fiber Oxygenator

- Pathway: 510(k) (Traditional)
- Applicant: Avecor Cardiovascular, Inc.
- Decided: Nov 19, 1993 after 177 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
No predicates in its family tree.
50 later devices descend from it; 3 cite it directly.
4 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K992559: Hollow Fiber Membrane Oygenator Quadrox Hmo 1010 (1999), 45 descendants of its own
- 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

Source page: https://510kreport.com/device/K932252
Methodology: https://510kreport.com/methodology