510(k) · Cleared
Recalled · 2009Cobe Revolution Centrifugal Blood Pump with PC, Model 050300700
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cobe Cardiovascular, Inc. · KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Cleared on Mar 6, 2003 as substantially equivalent to K011835 (Cobe Cardiovascular, Inc., 2002) and 2 other predicates after a 22-day review. Its family tree reaches back 3 generations to 1992. 9 later devices descend from it. It has been recalled once.
- Decided
- Mar 6, 2003
- Review
- 22 days
- Class
- Class II
- Product code
- KFM
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K922933 (1992). 7 ancestors in all, the oldest K852698 (1985). 9 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK922933 Sorin Monolyrh Integrated Membrane LungSorin Biomedica, Fiat, USA, Inc. · 1992
- 2 generations backK980600 D903 Avant Adult Hollow Fiber OxygenatorDideco S.P.A. · 1998
- 1 generation backK020351 D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber OxygenatorDideco S.P.A. · 2002
- This deviceK030462 Cobe Revolution Centrifugal Blood Pump with PC, Model 050300700Cobe Cardiovascular, Inc. · 2003
- Descendant · cites it directly · 4 of its ownK192850 Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow…Qura S.R.L · 2020
- Descendant · 2 generations on · 3 of its ownK202169 Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow…Qura S.R.L · 2020
- Descendant · 3 generations on · 2 of its ownK201320 Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated SensorQura S.R.L · 2021 · Recalled
- Descendant · cites it directly · 2 of its ownK032040 Ideal Mimesys System with Integrated Venous Air Removal, Centrifugal…Dideco S.P.A. · 2003 · Recalled
- Descendant · 2 generations on · 1 of its ownK050890 Ecc.O SystemDideco S.R.L. · 2005
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K192850Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22Qura S.R.L · 2020 · cites it directly4descendants
- K202169Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22Qura S.R.L · 2020 · 2 generations on3descendants
- K201320Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated SensorQura S.R.L · 2021 · 3 generations on2descendants
- K032040Ideal Mimesys System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump…Dideco S.P.A. · 2003 · cites it directly2descendants
- K050890Ecc.O SystemDideco S.R.L. · 2005 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K922933 | Sorin Monolyrh Integrated Membrane Lung | Sorin Biomedica, Fiat, USA, Inc. | 1992 | — |
| −2 | K980600 | D903 Avant Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 1998 | — |
| −1 | K020351 | D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 2002 | — |
| 0 (this device) | K030462 | Cobe Revolution Centrifugal Blood Pump with PC, Model 050300700 | Cobe Cardiovascular, Inc. | 2003 | — |
| +1 | K192850 | Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal… | Qura S.R.L | 2020 | — |
| +2 | K202169 | Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal… | Qura S.R.L | 2020 | — |
| +3 | K201320 | Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor | Qura S.R.L | 2021 | 1 |
| +1 | K032040 | Ideal Mimesys System with Integrated Venous Air Removal, Centrifugal Blood… | Dideco S.P.A. | 2003 | 1 |
| +2 | K050890 | Ecc.O System | Dideco S.R.L. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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? (3)
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.
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 25, 2009 | Not classified | Z-0193-2010 | Packaging change control | A weakness in the plastic packaging tray could cause the tray to crack; compromising product sterility. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K192850 (Qura S.R.L, 2020) has gone furthest, with 4 descendants of its own.
- 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.
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 pump is intended for use only with Stockert Instrumente Centrifugal Pump Consoles in cardiopulmonary bypass procedures for periods of up 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/K030462 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030462: Cobe Revolution Centrifugal Blood Pump with PC, Model 050300700.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030462
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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