# K960974: Cobe Century Perfusion Pump

- Pathway: 510(k) (Traditional)
- Applicant: Cobe Cardiovascular, Inc.
- Decided: Jul 14, 1997 after 490 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
No predicates in its family tree.
10 later devices descend from it; 3 cite it directly.
2 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) COBE Precision Blood Pump: named in the summary without a submission number

## Most influential descendants
- K052555: Medtronic Performer TM CPB, Model R51, PCPB (2006), 8 descendants of its own
- K090006: Lifebridge B2T, Model 7001 (2009), 5 descendants of its own
- K102726: Cardiohelp System (2011), 2 descendants of its own
- K070213: Performer CBP System (2007), 1 descendant of its own
- K202125: Century Perfusion System (2021), 0 descendants of its own

## Indications for use
The COBE Century™ Precision Blood Pump is intended for use in cardiopulmonary surgical procedures requiring pumping of fluids in an extracorporeal circuit for periods up to 6 hours.

Source page: https://510kreport.com/device/K960974
Methodology: https://510kreport.com/methodology