# K163531: Advanced Perfusion System 1

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Cardiovascular Systems Corporation
- Decided: Jun 7, 2017 after 173 days
- Product code: DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4220
- 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.
2 later devices descend from it; 1 cites 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)
- K153376: Advanced Perfusion System 1, Terumo Cardiovascular Systems Corporation (2015) Summary page 4.

## Most influential descendants
- K172220: Advanced Perfusion System 1 (2017), 1 descendant of its own
- K221895: Terumo Advanced Perfusion System 1 (2023), 0 descendants of its own

## Indications for use
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. The centrifugal pump is indicated for use in cardiopulmonary bypass procedures only.

Source page: https://510kreport.com/device/K163531
Methodology: https://510kreport.com/methodology