# K202125: Century Perfusion System

- Pathway: 510(k) (Traditional)
- Applicant: Century Hlm, LLC
- Decided: Mar 7, 2021 after 219 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: 1 generation back to K960974 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060053: Stockert S5 System, Sorin Group Deutschland GmbH (2006) Summary page 5.
- K960974: Cobe Century Perfusion Pump, Cobe Cardiovascular, Inc. (1997) Summary page 6.

## Indications for use
The Century Perfusion System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.

Source page: https://510kreport.com/device/K202125
Methodology: https://510kreport.com/methodology