# K112587: Advanced Perfusion System 1 (APS1) Tube Clamp Assembly, Roller Pump 6 Inch Classic Color,

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Cardiovascular Systems Corp.
- Decided: Dec 19, 2011 after 104 days
- Product code: DWB (Pump, Blood, Cardiopulmonary Bypass, Roller Type)
- Device class: 2
- Regulation: 21 CFR 870.4370
- 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 K915183 (1992). 4 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953901: Sarns 800  Roller Pump, 3M Health Care, Sarns (1996) Summary page 1.
- K953904: Sarns 9000 Universal Roller Pump, 3M Health Care, Ltd. (1996) Summary page 1.

## Most influential descendants
- K131041: Advanced Perfusion System 1 (2014), 6 descendants of its own
- K151349: Advanced Perfusion System 1 (2015), 5 descendants of its own
- K153376: Advanced Perfusion System 1 (2015), 4 descendants of its own
- K163531: Advanced Perfusion System 1 (2017), 2 descendants of its own
- K172220: Advanced Perfusion System 1 (2017), 1 descendant of its own

## Indications for use
The Large (6") Roller Pump for the Terumo® Advanced Perfusion System 1 is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

Source page: https://510kreport.com/device/K112587
Methodology: https://510kreport.com/methodology