# K013526: Capiox RX Hardshell Reservoir

- Pathway: 510(k) (Special)
- Applicant: Terumo Cardiovascular Systems Corp.
- Decided: Nov 15, 2001 after 23 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: 1 generation back to K002238 (2000). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002238: Capiox SX Hardshell Reservoir with X-Coating, Terumo Cardiovascular Systems Corp. (2000) Summary page 1.

## Most influential descendants
- K130359: Capiox SX18 Hollow Fiber Oxygenator with Detachable Hardshell Reservoir, Capiox SX25 Hollow Fiber Oxgenator with Detacha (2013), 2 descendants of its own
- K153143: Capiox Advance Hardshell Reservoir (2015), 0 descendants of its own
- K153140: Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir with Xcoating, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir with Xcoating (2015), 0 descendants of its own
- K030505: Capiox Cardiotomy Reservoir (2003), 0 descendants of its own

## Indications for use
The CAPIOX® RX 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 blood to the patient for blood volume replacement. The Hardshell Reservoir is also used with the vacuum-assisted venous return technique during cardiopulmonary bypass. The Hardshell Reservoir contains X-Coating, which is intended to reduce platelet adhesion on the surfaces of the device. The device may be used for procedures lasting up to 6 hours

Source page: https://510kreport.com/device/K013526
Methodology: https://510kreport.com/methodology