# K153376: Advanced Perfusion System 1

- Pathway: 510(k) (Special)
- Applicant: Terumo Cardiovascular Systems Corporation
- Decided: Dec 16, 2015 after 23 days
- Product code: DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4220
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K915183 (1992). 9 ancestors in all.
4 later devices descend from it; 2 cite 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)
- K151349: Advanced Perfusion System 1, Terumo Cardiovascular Systems Corporation (2015) Summary page 4.

## Most influential descendants
- 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
- K162843: Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1 (2016), 0 descendants of its own

## Recalls of this device
- Feb 20, 2017 · Class II · Z-1458-2017: Terumo CVS initiated a voluntary recall for the Level Sensor II Pads and Level Sensor Gel Pads due to non-compliant labeling because the product expiration date is displayed in a format that may not b
- Feb 20, 2017 · Class II · Z-1459-2017: Terumo CVS initiated a voluntary recall for the Level Sensor II Pads and Level Sensor Gel Pads due to non-compliant labeling because the product expiration date is displayed in a format that may not b

## 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/K153376
Methodology: https://510kreport.com/methodology