# K960074: Capiox SX10 Hollow Fiber Oxygenator with Detachable Hardshell Venous Reservoir

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corp.
- Decided: Oct 16, 1996 after 279 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.
44 later devices descend from it; 3 cite it directly.
2 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K051997: Capiox RX15 Hollow, Fiber Oxygenator with/Without Hardshell Reservoir (2005), 25 descendants of its own
- K991452: Cobe Optimin Hollow Fiber Membrane Oxygenator (1999), 19 descendants of its own
- K043323: D 905 Eos Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy Reservoir (2005), 17 descendants of its own
- K090689: Quadrox-I Small Adult with and Without Intergrated Arterial Filter with Softline Coating, Models Hmo 50000, Hmo 51000 (2009), 9 descendants of its own
- K062381: Capiox RX Oxygenator with or Without Reservoir (2006), 9 descendants of its own

Source page: https://510kreport.com/device/K960074
Methodology: https://510kreport.com/methodology