# K011804: Capiox Arterial Filter with X-Coating, Product Code CX*AFO2X

- Pathway: 510(k) (Special)
- Applicant: Terumo Cardiovascular Systems Corp.
- Decided: Jul 9, 2001 after 28 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
Longest line of descent: 1 generation back to K943917 (1995). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943917: Capiox Arterial Filter, Terumo Medical Corp. (1995) Summary page 1.

## Most influential descendants
- K071572: Capiox FX05 Hollow Fiber Oxygenator with Integrated Arterial Filter (2007), 1 descendant of its own
- K130280: Capiox FX Hollow Fiber Oxygenator W/ Reservoir (2013), 0 descendants of its own
- K083747: Terumo Pall AL3X Arterial Filter (2009), 0 descendants of its own

## Indications for use
The CAPIOX® Arterial Filter with X-Coating is a pediatric filter that is intended to filtrate non-biologic particles and emboli, and to facilitate air bubble removal from the blood flowing through a cardiopulmonary bypass circuit for up to 6 hours. The polymethoxyethylacrylate coating (PMEA) is intended to reduce the adhesion of platelets to the blood-contacting surfaces of the device.

Source page: https://510kreport.com/device/K011804
Methodology: https://510kreport.com/methodology