# K131041: Advanced Perfusion System 1

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Cardiovascular Systems Corp.
- Decided: Feb 20, 2014 after 311 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: 3 generations back to K915183 (1992). 7 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022947: Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System 1 (220/240 Volt, Roller Pumps (6, 4 Inch, Terumo Cardiovascular Systems Corp. (2003) Summary page 1.
- K112587: Advanced Perfusion System 1 (APS1) Tube Clamp Assembly, Roller Pump 6 Inch Classic Color,, Terumo Cardiovascular Systems Corp. (2011) Summary page 1.

## Most influential descendants
- 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
- 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/K131041
Methodology: https://510kreport.com/methodology