# K002238: Capiox SX Hardshell Reservoir with X-Coating

- Pathway: 510(k) (Special)
- Applicant: Terumo Cardiovascular Systems Corp.
- Decided: Aug 22, 2000 after 29 days
- Product code: DTN (Reservoir, Blood, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 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
- K013526: Capiox RX Hardshell Reservoir (2001), 4 descendants of its own
- K130359: Capiox SX18 Hollow Fiber Oxygenator with Detachable Hardshell Reservoir, Capiox SX25 Hollow Fiber Oxgenator with Detacha (2013), 2 descendants of its own
- K153143: Capiox Advance Hardshell Reservoir (2015), 0 descendants of its own
- K153140: Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir with Xcoating, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir with Xcoating (2015), 0 descendants of its own
- K030505: Capiox Cardiotomy Reservoir (2003), 0 descendants of its own

Source page: https://510kreport.com/device/K002238
Methodology: https://510kreport.com/methodology