# K002026: Capiox Arterial Filter

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corp.
- Decided: Sep 6, 2000 after 65 days
- Product code: DTM (Filter, Blood, Cardiopulmonary Bypass, Arterial Line)
- Device class: 2
- Regulation: 21 CFR 870.4260
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 1 cites it directly.
0 of 11 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
- K052205: Capiox AF125X Arterial Filter (2005), 9 descendants of its own
- K071494: Capiox FX15 and FX25 Hollow Fiber Oxygenator and Arterial Filter (2007), 7 descendants of its own
- K130520: Capiox FX15 and FX25 Hollow Fiber Oxygenator/Reservoir (2013), 6 descendants of its own
- K140774: Terumo Capiox FX15 and FX25 Hollow Fiber Oxygenator/Reservoir (2014), 5 descendants of its own
- K151791: Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir, Terumo Capiox FX25 Advance Oxygenator with Integrated Arterial Filter and Reservoir (2015), 2 descendants of its own

Source page: https://510kreport.com/device/K002026
Methodology: https://510kreport.com/methodology