# K961000: Capiox SX18 Hollow Fiber Oxygenator with and Without Detachable Hardshell Reservoir

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corp.
- Decided: Oct 2, 1996 after 204 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.
4 later devices descend from it; 2 cite it directly.
0 of 5 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) Cobe CML Excel: named in the summary without a submission number

## 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
- K970463: Capiox E Hollow Fiber Oxygenator with Integrated Heat Exchanger/Arterial Reservoir (1997), 0 descendants of its own

## Indications for use
The CAPIOX® SX18 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 SX18 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/K961000
Methodology: https://510kreport.com/methodology