# K131618: Large (6) Roller Pump for Terumo Advanced Perfusion System 1; Large (6) Roller Pump for Terumo Advanced Perfusion Syst

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Cardiovascular Systems Corporation
- Decided: Sep 27, 2013 after 116 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: 3 generations back to K915183 (1992). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112587: Advanced Perfusion System 1 (APS1) Tube Clamp Assembly, Roller Pump 6 Inch Classic Color,, Terumo Cardiovascular Systems Corp. (2011) Summary page 7.

## 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/K131618
Methodology: https://510kreport.com/methodology