# K162843: Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1

- Pathway: 510(k) (Special)
- Applicant: Terumo Cardiovascular Systems Corporation
- Decided: Nov 17, 2016 after 37 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: 6 generations back to K915183 (1992). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153376: Advanced Perfusion System 1, Terumo Cardiovascular Systems Corporation (2015) Summary page 4.

## Indications for use
The Small (4”) and Large (6”) Roller Pumps of the Terumo® Advanced Perfusion System 1 are 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/K162843
Methodology: https://510kreport.com/methodology