# K090698: Capiox Bubble Trap with X-Coating

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Cardiovascular Systems
- Decided: Jun 8, 2009 after 83 days
- Product code: KRL (Detector, Bubble, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4205
- 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 K911632 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911632: Capiox (R) Bubble Trap, Terumo Medical Corp. (1991) Summary page 1.

## Indications for use
The Capiox ® Bubble Trap with X-coatingMT is a device intended to facilitate air bubble removal from the blood flowing through a cardiopulmonary bypass circuit for up to 6 hours.

Source page: https://510kreport.com/device/K090698
Methodology: https://510kreport.com/methodology