# K962667: Capiox SX25 Hollow Fiber Oxygenator with Detachable Hardshell Reservoir

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corp.
- Decided: Oct 7, 1996 after 90 days
- Product code: DTZ (Oxygenator, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
16 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) CAPIOX SX18 Oxygenator and Hardshell Reservoir: named in the summary without a submission number

## Most influential descendants
- K040210: Capiox RX25 Hollow Fiber Oxygenator W/WO Hardshell Reservoir (2004), 12 descendants of its own
- K062381: Capiox RX Oxygenator with or Without Reservoir (2006), 9 descendants of its own
- K130333: Capix RX Hollow Fiber Oxygenator with/Without Hardshell Reservoir (2013), 7 descendants of its own
- K071494: Capiox FX15 and FX25 Hollow Fiber Oxygenator and Arterial Filter (2007), 7 descendants of its own
- K130520: Capiox FX15 and FX25 Hollow Fiber Oxygenator/Reservoir (2013), 6 descendants of its own

## Indications for use
The CAPIOX® SX25 Hollow Fiber Oxygenator is used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery. The integral heat exchanger is used to warm or cool the blood or perfusion fluid flowing through the device. The CAPIOX SX25 Hardshell Reservoir (detachable) is 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.

Source page: https://510kreport.com/device/K962667
Methodology: https://510kreport.com/methodology