# K982223: Capiox SX Hardshell Resevoir

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corp.
- Decided: Sep 10, 1998 after 78 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 K915573 (1992). 2 ancestors in all.
28 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)
- K915573: Venous Reservoir W/Cardiotomy Filter, Baxter Healthcare Corp (1992) Summary page 2.
- K974155: BMR 4500 Filtered Venous Reservoir and BMR -4500 Gold Filtered Venous Reservoir with Duraflo Treatment, Baxter Healthcare Corp (1998). Our OCR of the scanned summary read K971455, FDA’s number for Clarus Model 5197 Sightlite (Clarus Medical Systems, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Bentley BMR Venous Reservoir”.

## Most influential descendants
- K991973: Capiox SX10 Hardshell Resevoir (1999), 27 descendants of its own
- 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

## 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 The Hardshell Reservoir is also used with the vacuum-assisted venous return technique during cardiopulmonary bypass.

Source page: https://510kreport.com/device/K982223
Methodology: https://510kreport.com/methodology