510(k) · Cleared
ClearedRevolution Centrifugal Blood Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sorin Group Italia S.R.L. · KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Cleared on Aug 7, 2019 as substantially equivalent to K011835 (Cobe Cardiovascular, Inc., 2002) and 1 other predicate after a 147-day review. Its family tree reaches back 4 generations to 1992.
- Decided
- Aug 7, 2019
- Review
- 147 days
- Class
- Class II
- Product code
- KFM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K922933 (1992). 8 ancestors in all, the oldest K852698 (1985). No later device cites it as a predicate yet.
- Root · 4 generations backK922933 Sorin Monolyrh Integrated Membrane LungSorin Biomedica, Fiat, USA, Inc. · 1992
- 3 generations backK980600 D903 Avant Adult Hollow Fiber OxygenatorDideco S.P.A. · 1998
- 2 generations backK020351 D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber OxygenatorDideco S.P.A. · 2002
- 1 generation backK030462 Cobe Revolution Centrifugal Blood Pump with PC, Model 050300700Cobe Cardiovascular, Inc. · 2003 · Recalled
- This deviceK190650 Revolution Centrifugal Blood PumpSorin Group Italia S.R.L. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K922933 | Sorin Monolyrh Integrated Membrane Lung | Sorin Biomedica, Fiat, USA, Inc. | 1992 | — |
| −3 | K980600 | D903 Avant Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 1998 | — |
| −2 | K020351 | D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 2002 | — |
| −1 | K030462 | Cobe Revolution Centrifugal Blood Pump with PC, Model 050300700 | Cobe Cardiovascular, Inc. | 2003 | 1 |
| 0 (this device) | K190650 | Revolution Centrifugal Blood Pump | Sorin Group Italia S.R.L. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KFM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KFM device
- #1 K250326 Quantum Perfusion Centrifugal Blood Pump…score 11.4 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K011835 | Cobe RevolutionSummary page 6…ogy and intended use: 510(k) – Centrifugal Blood Pumps Page 7-1 510(k) Number: K011835 Proprietary Name: Revolution Centrifugal Blood Pump Common/Usual Name: Nonroller-type card… | 2002 |
| * | K030462 | Cobe Revolution Centrifugal Blood Pump with PC, Model 050300700Summary page 6…the following cleared predicate device. Both models have the same fundamental scientific technology and intended use: 510(k) Number: K030462 Proprietary Name: Revolution Centrifugal Blood Pump with PC Coating… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- 2 of the 8 ancestors have a recall of any class.
- 3 other devices also cite its predicate K011835.
How does its category compare?
All KFM devicesKFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · KFM
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KFM
30in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KFM
2in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KFM
249in 2025
MAUDE reports naming product code KFM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 60 |
| 2008 | 4 | 194 | 2 | 62 |
| 2009 | 5 | 184 | 4 | 85 |
| 2010 | 3 | 109 | 2 | 81 |
| 2011 | 7 | 16 | 1 | 57 |
| 2012 | 0 | — | 5 | 82 |
| 2013 | 2 | — | 0 | 104 |
| 2014 | 0 | — | 0 | 347 |
| 2015 | 0 | — | 0 | 299 |
| 2016 | 0 | — | 0 | 156 |
| 2017 | 1 | — | 0 | 121 |
| 2018 | 0 | — | 1 | 176 |
| 2019 | 3 | 147 | 3 (1) | 311 |
| 2020 | 3 | 30 | 0 | 437 |
| 2021 | 3 | 534 | 0 | 446 |
| 2022 | 0 | — | 0 | 294 |
| 2023 | 3 | 30 | 0 | 346 |
| 2024 | 0 | — | 2 | 296 |
| 2025 | 2 | — | 0 | 249 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (157 words)
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190650 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190650: Revolution Centrifugal Blood Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190650
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026