# K190650: Revolution Centrifugal Blood Pump

- Pathway: 510(k) (Traditional)
- Applicant: Sorin Group Italia S.R.L.
- Decided: Aug 7, 2019 after 147 days
- Product code: KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type)
- Device class: 2
- Regulation: 21 CFR 870.4360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K922933 (1992). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011835: Cobe Revolution, Cobe Cardiovascular, Inc. (2002) Summary page 6.
- K030462: Cobe Revolution Centrifugal Blood Pump with PC, Model 050300700, Cobe Cardiovascular, Inc. (2003) Summary page 6.

## Indications for use
The Revolution Centrifugal Blood Pump is intended to be used with a LivaNova Centrifugal Pump Console in cardiopulmonary bypass procedures for periods of us to six hours. Refer to the console operator's manual for console operating procedures. The pump has not been qualified through in vitro, in vivo, or clinical studies for long term use (i.e., longer than six hours) as a bridge to transplant, for pending recovery of the natural heart or extracorporeal membrane oxygenation (ECMO). The Revolution Centrifugal Blood Pump with PC Coating is intended to be used with a LivaNova Centrifugal Pump Console in cardiopulmonary bypass procedures for periods of us to six hours. Refer to the console operator's manual for console operating procedures. The pump has not been qualified through in vitro, in vivo, or clinical studies for long term use (i.e., longer than six hours) as a bridge to transplant, for pending recovery of the natural heart or extracorporeal membrane oxygenation (ECMO).

Source page: https://510kreport.com/device/K190650
Methodology: https://510kreport.com/methodology