510(k) · Cleared
Recalled · Class II · 2020Rotaflow Centrifugal Pump System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jostra Medizintechnik AG · KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Cleared on Aug 31, 2000 after a 457-day review. The FDA summary names its predicate without a number. 4 of the 31 devices in its family, counting itself, have a Class I recall. 30 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 31, 2000
- Review
- 457 days
- Class
- Class II
- Product code
- KFM
- Recalls
- 2
- Predicates
- 0
30 later devices descend from it, 9 citing it directly. 4 of the 31 devices in this family, counting this one, have a Class I recall.
- This deviceK991864 Rotaflow Centrifugal Pump SystemJostra Medizintechnik AG · 2000
- Descendant · cites it directly · 10 of its ownK061072 Rotaflow Centrifugal Pump with Safeline Coating, Model BSQ-RF-32Maquet Cardiopulmonary, AG · 2006
- Descendant · cites it directly · 4 of its ownK011838 Centrifugal PumpStockert Instrumente GmbH · 2002 · Recalled
- Descendant · cites it directly · 3 of its ownK191407 Novalung SystemFresenius Medical Care Renal Therapies Group, LLC · 2020 · Recalled
- Descendant · 2 generations on · 3 of its ownK061743 Venous Hardshell Cardiotomy Reservoir W/Safeline Coating, Model…Maquet Cardiopulmonary, AG · 2006
- Descendant · cites it directly · 2 of its ownK200109 OXY-1 SystemAbiomed, Inc. · 2020 · Recalled (Class I)
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 30 · See all- K061072Rotaflow Centrifugal Pump with Safeline Coating, Model BSQ-RF-32Maquet Cardiopulmonary, AG · 2006 · cites it directly10descendants
- K011838Centrifugal PumpStockert Instrumente GmbH · 2002 · cites it directly4descendants
- K191407Novalung SystemFresenius Medical Care Renal Therapies Group, LLC · 2020 · cites it directly3descendants
- K061743Venous Hardshell Cardiotomy Reservoir W/Safeline Coating, Model BSQ-VHK 2000;Vacuum…Maquet Cardiopulmonary, AG · 2006 · 2 generations on3descendants
- K200109OXY-1 SystemAbiomed, Inc. · 2020 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991864 | Rotaflow Centrifugal Pump System | Jostra Medizintechnik AG | 2000 | — |
| +1 | K061072 | Rotaflow Centrifugal Pump with Safeline Coating, Model BSQ-RF-32 | Maquet Cardiopulmonary, AG | 2006 | — |
| +1 | K011838 | Centrifugal Pump | Stockert Instrumente GmbH | 2002 | 4 |
| +1 | K191407 | Novalung System | Fresenius Medical Care Renal Therapies Group, LLC | 2020 | 2 |
| +2 | K061743 | Venous Hardshell Cardiotomy Reservoir W/Safeline Coating, Model BSQ-VHK… | Maquet Cardiopulmonary, AG | 2006 | — |
| +1 | K200109 | OXY-1 System | Abiomed, Inc. | 2020 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2006 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2011 | 3 | 1 |
| 2013 | 1 | 0 |
| 2014 | 2 | 2 |
| 2017 | 1 | 0 |
| 2020 | 3 | 1 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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.
4 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? (4)
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 |
|---|---|---|---|
| * | — | Medtronic Bio-Medicus Bio-Console Model 550 Named without a submission number | |
| * | — | Medtronic Bio-Medicus Bio-Pump Centrifugal Blood Pump BP 80 Named without a submission number | |
| * | — | St. Jude Medical Pulse 2100 Centrifugal Pump Interface Named without a submission number | |
| * | — | Medtronic Bio-Probe DP-38 Named without a submission number |
What descends from it? (30)
See all 309 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061072 | Rotaflow Centrifugal Pump with Safeline Coating, Model BSQ-RF-32 | 2006 | 10 |
| K011838 | Centrifugal Pump | 2002 | 4 |
| K191407 | Novalung System | 2020 | 3 |
| K200109 | OXY-1 System Class I | 2020 | 2 |
| K102726 | Cardiohelp System Class I | 2011 | 2 |
| K170029 | FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile | 2017 | 1 |
| K021694 | Cardiovention Powerbase Console, Model PBC-100 | 2003 | 1 |
| K232788 | Inspira ART100 | 2024 | 0 |
| K020571 | Stockert Centrifugal Pump Console | 2002 | 0 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 7, 2020 | Class III | Z-2957-2020 | Labeling Change Control | Instruction For Use (IFU) references incorrect serial number of 90437000. It should state This document applies to ROTAFLOW Consoles as of serial number 94175452 affected by the implementation of the new IEC standard 60601 1 2, 4th edition |
| Dec 3, 2019 | Class II | Z-0678-2020 | Nonconforming Material/Component | A loose ODU plug / Coaxial cable connection may result in fluctuating flow values on the Console. |
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.
- K200109OXY-1 SystemAbiomed, Inc. · 2020 · Cites it directly · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K133598Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
- K141432Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell Cardiotomy Reservior, Neonatal…Maquet Cardiopulmonary, AG · 2014 · 5 generations on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K061072 (Maquet Cardiopulmonary, AG, 2006) has gone furthest, with 10 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.
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 System is intended for use in an extracorporeal perfusion circuit to pump blood during short duration cardiopulmonary bypass procedures lasting 6 hours or less.
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/K991864 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991864: Rotaflow Centrifugal Pump System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991864
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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