# K980935: Capiox SX Hardshell Reservoir

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corp.
- Decided: May 14, 1998 after 63 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
Longest line of descent: 2 generations back to K891230 (1989). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961836: Maxima Forte Hardshell Venous Reservoir, Medtronic Vascular (1996) Summary page 2.

## Indications for use
The CAPIOX SX Hardshell Reservoir is a hardshell reservoir used to store blood during extracorporeal circulation from both the venous line and the cardiotomy line. The reservoir contains filters to remove particulate matter and defoamers to facilitate air bubble removal. The Hardshell Reservoir is also used for post-operative chest drainage and autotransfusion procedures to aseptically return the blood to the patient for blood volume replacement.

Source page: https://510kreport.com/device/K980935
Methodology: https://510kreport.com/methodology