510(k) · Cleared
Recalled · Class II · 2018Levitronix Pedimag Blood Pump, Model 201-90052
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 Oct 8, 2009 as substantially equivalent to K020271 (Levitronix, LLC, 2003) and 1 other predicate after a 274-day review. Its family tree reaches back 3 generations to 1985. 1 of the 10 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it. It has been recalled once.
- Decided
- Oct 8, 2009
- Review
- 274 days
- Class
- Class II
- Product code
- KFM
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K852698 (1985). 7 ancestors in all, the oldest K852807 (1985). 2 later devices descend from it, 1 citing it directly. 1 of the 10 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 deviceK090051 Levitronix Pedimag Blood Pump, Model 201-90052Levitronix, LLC · 2009
- Descendant · cites it directly · 1 of its ownK220842 Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated…Qura S.R.L · 2023
- Descendant · 2 generations on · 0 of its ownK251762 Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated…Spectrum Medical S.R.L. · 2025
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) | K090051 | Levitronix Pedimag Blood Pump, Model 201-90052 | Levitronix, LLC | 2009 | — |
| +1 | K220842 | Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum… | Qura S.R.L | 2023 | — |
| +2 | K251762 | Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors… | Spectrum Medical S.R.L. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
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? (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 |
|---|---|---|---|
| * | K020271 | Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100Summary page 1…he Food, Drug and Cosmetic Act. C. Legally Marketed Predicate Devices · Levitronix CentriMag Blood Pump (K020271) * Medtronic Bio-Pump BP-50 Centrifugal Blood Pump (K852807) D. Device Description The PediMag Blood Pum… | 2003 |
| * | K852807 | Bio Medicus Bio Pump Model BP-50Summary page 1…metic Act. C. Legally Marketed Predicate Devices · Levitronix CentriMag Blood Pump (K020271) * Medtronic Bio-Pump BP-50 Centrifugal Blood Pump (K852807) D. Device Description The PediMag Blood Pump is a sterile, single-use, disposable, non-coated, polycarbon… | 1985 |
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 |
|---|---|---|---|
| K220842 | Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion… | 2023 | 1 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 5, 2018 | Class II | Z-0103-2019 | Device Design | Reports of circulatory support system motor stopping. Motor stop can be attributed to a break of a wire or short circuit between wires within the electrical cable where the cable exits the motor cable bend protection. |
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 24 years and passes through 3 companies; a new generation was cleared every 6.5 years on median.
- 4 of the 7 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K220842 (Qura S.R.L, 2023) 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. 2009, 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 PediMag Blood Pump is indicated for use with the CentriMag Console and Motor to pump blood through a complete extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours) for surgical procedures such as a mitral valve reoperation. It is also indicated for use in extracorporeal support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g.…
Read the full statement (117 words)
The PediMag Blood Pump is indicated for use with the CentriMag Console and Motor to pump blood through a complete extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours) for surgical procedures such as a mitral valve reoperation. It is also indicated for use in extracorporeal support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g. valvuloplasty, surgery of the vena cava or aorta, liver transplants etc.).
The PediMag Pump can generate a maximum pump flow equal to 1.5 liters per minute, limiting its use to pediatric patients.
The Levitronix PediMag Blood Pump is indicated for use only with the Levitronix CentriMag Console and Motor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090051 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090051: Levitronix Pedimag Blood Pump, Model 201-90052.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090051
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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