# K991973: Capiox SX10 Hardshell Resevoir

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corp.
- Decided: Sep 3, 1999 after 84 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 K915573 (1992). 3 ancestors in all.
27 later devices descend from it; 1 cites it directly.
2 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982223: Capiox SX Hardshell Resevoir, Terumo Medical Corp. (1998) Summary page 1.

## Most influential descendants
- K030449: Modification to Capiox SX10 Hardshell Reservoir (2003), 26 descendants of its own
- K051997: Capiox RX15 Hollow, Fiber Oxygenator with/Without Hardshell Reservoir (2005), 25 descendants of its own
- K090689: Quadrox-I Small Adult with and Without Intergrated Arterial Filter with Softline Coating, Models Hmo 50000, Hmo 51000 (2009), 9 descendants of its own
- K062381: Capiox RX Oxygenator with or Without Reservoir (2006), 9 descendants of its own
- K093522: Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline Coating and W/ Integrated Arterial Filter W/ Bioline C (2009), 8 descendants of its own

## Indications for use
The CAPIOX® SX10 Hardshell Reservoir is a hardshell reservoir used to store blood during extracorporeal circulation from both the venous line and the cardiotomy line during cardiopulmonary bypass procedures lasting up to 6 hours. The reservoir contains filters to remove particulate matter and defoamers to facilitate air bubble removal. The Hardshell Reservoir is also used with the vacuum-assisted venous return technique during cardiopulmonary bypass procedures lasting up to 6 hours

Source page: https://510kreport.com/device/K991973
Methodology: https://510kreport.com/methodology