# K922799: Capiox SX Hollow Fiber Oxygenator

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corp.
- Decided: Sep 2, 1993 after 449 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.
6 later devices descend from it; 2 cite it directly.
0 of 7 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
- K964973: Gish Cap VRF45 Cardiotomy/Venous Reservoir (1997), 3 descendants of its own
- K030726: Gish CAPVRF44 Hardshell Venous Reservoir with GBS Coating (2003), 1 descendant of its own
- K961836: Maxima Forte Hardshell Venous Reservoir (1996), 1 descendant of its own
- K083131: Medos Hilite Reservoir, Model: 4030 (2009), 0 descendants of its own
- K081947: Gish CAPVRF44 Hardshell Venous Reservoir with HA Coating (2009), 0 descendants of its own

Source page: https://510kreport.com/device/K922799
Methodology: https://510kreport.com/methodology