510(k) · Cleared
Recalled · Class II · 2024Rota Flow Centrifugal Pump with Bioline Coating, Models BE-RF-32, Beq-RF-32
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maquet Cardiopulmonary, AG · KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Cleared on Sep 12, 2008 after a 204-day review. The FDA summary names its predicate without a number. 2 of the 5 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 12, 2008
- Review
- 204 days
- Class
- Class II
- Product code
- KFM
- Recalls
- 2
- Predicates
- 0
4 later devices descend from it, 2 citing it directly. 2 of the 5 devices in this family, counting this one, have a Class I recall.
- This deviceK080470 Rota Flow Centrifugal Pump with Bioline Coating, Models BE-RF-32…Maquet Cardiopulmonary, AG · 2008
- Descendant · cites it directly · 2 of its ownK102726 Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK133598 Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK133265 Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG · 2013
- Descendant · cites it directly · 0 of its ownK090515 Rotaflow Centrifugal Pump with Softline Coating, Model BO-RF-32 (Usa)Maquet Cardiopulmonary, AG · 2009 · Recalled
Class I recalls in this family
Most influential descendants
Showing 4 of 4 · See all- K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · cites it directly2descendants
- K133598Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · 2 generations on0descendants
- K133265Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG · 2013 · 2 generations on0descendants
- K090515Rotaflow Centrifugal Pump with Softline Coating, Model BO-RF-32 (Usa)Maquet Cardiopulmonary, AG · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K080470 | Rota Flow Centrifugal Pump with Bioline Coating, Models BE-RF-32, Beq-RF-32 | Maquet Cardiopulmonary, AG | 2008 | — |
| +1 | K102726 | Cardiohelp System | Maquet Cardiopulmonary, AG | 2011 | Class I |
| +2 | K133598 | Cardiohelp System | Maquet Cardiopulmonary, AG | 2014 | Class I |
| +2 | K133265 | Quadrox-IR Adult and Small Adult | Maquet Cardiopulmonary, AG | 2013 | — |
| +1 | K090515 | Rotaflow Centrifugal Pump with Softline Coating, Model BO-RF-32 (Usa) | Maquet Cardiopulmonary, AG | 2009 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 1 |
| 2013 | 1 | 0 |
| 2014 | 1 | 1 |
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.
2 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | — | RotaFlow Centrifugal Pump with Safeline Coating Named without a submission number | |
| * | — | Quadrox D Diffusion Membrane Oxygenator with Bioline Coating Named without a submission number |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 8, 2024 | Class II | Z-0977-2024 | Process control | Nonconformities at their seal could potentially compromise the sterile barrier for affected products. Breach of sterile barrier could expose patients to pathogenic agents, resulting in the following potential harms: inflammation… |
| Feb 23, 2016 | Class II | Z-1373-2016 | Unknown/Undetermined by firm | Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- Of its descendants, K102726 (Maquet Cardiopulmonary, AG, 2011) has gone furthest, with 2 descendants of its own.
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. 2008, 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 Rotaflow Centrifugal Pump is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:
* Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vesscls: or
* Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K080470 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080470: Rota Flow Centrifugal Pump with Bioline Coating, Models BE-RF-32, Beq-RF-32.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080470
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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