510(k) · Cleared
Recalled · 2008Levitronix Centrimag Back-UP Console
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Levitronix, LLC · KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Cleared on Sep 8, 2005 as substantially equivalent to K020271 (Levitronix, LLC, 2003) after a 120-day review. Its family tree reaches back 3 generations to 1985. 1 of the 9 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it. It has been recalled once.
- Decided
- Sep 8, 2005
- Review
- 120 days
- Class
- Class II
- Product code
- KFM
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K852698 (1985). 6 ancestors in all. 2 later devices descend from it, 1 citing it directly. 1 of the 9 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK852698 Bio Medicus Bio Pump Model BP-80Bio Medicus, Inc. · 1985
- 2 generations backK973011 BPX80 Bio-Pump (BPX80)Medtronic Bio-Medicus, Inc. · 1998
- 1 generation backK020271 Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100Levitronix, LLC · 2003 · Recalled (Class I)
- This deviceK051209 Levitronix Centrimag Back-UP ConsoleLevitronix, LLC · 2005
- Descendant · cites it directly · 1 of its ownK090004 Levitronix, Thoratec Centrimag Back-UP ConsolesLevitronix, LLC · 2009 · Recalled
- Descendant · 2 generations on · 0 of its ownK093832 Levitronix Centrimag Primary and Backup ConsolesLevitronix, LLC · 2010
Class I recalls in this family
- K020271 Levitronix Centrimag Extracorporeal Blood…direct predicate · 2003
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K852698 | Bio Medicus Bio Pump Model BP-80 | Bio Medicus, Inc. | 1985 | — |
| −2 | K973011 | BPX80 Bio-Pump (BPX80) | Medtronic Bio-Medicus, Inc. | 1998 | — |
| −1 | K020271 | Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100 | Levitronix, LLC | 2003 | Class I |
| 0 (this device) | K051209 | Levitronix Centrimag Back-UP Console | Levitronix, LLC | 2005 | — |
| +1 | K090004 | Levitronix, Thoratec Centrimag Back-UP Consoles | Levitronix, LLC | 2009 | 1 |
| +2 | K093832 | Levitronix Centrimag Primary and Backup Consoles | Levitronix, LLC | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 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.
1 device in this family has 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? (1)
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 |
|---|---|---|---|
| * | K020271 | Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100Summary page 1…section 514 of the Food, Drug and Cosmetic Act. C. Predicate Device: Levitronix CentriMag Console (K020271) Levitronix LLC special 510(k); Device Modification Page 89 of 92… | 2003 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090004 | Levitronix, Thoratec Centrimag Back-UP Consoles | 2009 | 1 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 17, 2008 | Not classified | Z-1902-2008 | Device Design | Stops pumping: Interruption of CentriMag System support may occur when using a Valleylab Force FX-C Electrocautery Unit |
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.
- K020271Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100Levitronix, LLC · 2003 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- 4 of the 6 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K090004 (Levitronix, LLC, 2009) has gone furthest, with 1 descendant of its own.
- 9 other devices also cite its predicate K020271.
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 Levitronix CentriMag Back-Up Console is indicated for use with the Levitronix CentriMag Extracorporeal Blood Pumping System and as a back-up to the CentriMag Primary Console. The Levitronix CentriMag Extracorporeal Blood Pumping System is indicated to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in…
Read the full statement (97 words)
The Levitronix CentriMag Back-Up Console is indicated for use with the Levitronix CentriMag Extracorporeal Blood Pumping System and as a back-up to the CentriMag Primary Console. The Levitronix CentriMag Extracorporeal Blood Pumping System is indicated to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051209 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051209: Levitronix Centrimag Back-UP Console.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051209
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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