510(k) · Cleared
ClearedBio Medicus Bio Pump Model BP-80
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio Medicus, Inc. · KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Cleared on Sep 30, 1985 after a 96-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 of the 67 devices in its family, counting itself, have a Class I recall. 66 later devices descend from it.
- Decided
- Sep 30, 1985
- Review
- 96 days
- Class
- Class II
- Product code
- KFM
- Recalls
- None
- Predicates
- 0
66 later devices descend from it, 4 citing it directly. 4 of the 67 devices in this family, counting this one, have a Class I recall.
- This deviceK852698 Bio Medicus Bio Pump Model BP-80Bio Medicus, Inc. · 1985
- Descendant · cites it directly · 48 of its ownK973011 BPX80 Bio-Pump (BPX80)Medtronic Bio-Medicus, Inc. · 1998
- Descendant · 2 generations on · 21 of its ownK020271 Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100Levitronix, LLC · 2003 · Recalled (Class I)
- Descendant · cites it directly · 13 of its ownK991783 AB-180 XC System, Model AB-180XCCardiacassist, Inc. · 2000
- Descendant · cites it directly · 12 of its ownK011835 Cobe RevolutionCobe Cardiovascular, Inc. · 2002 · Recalled
- Descendant · 3 generations on · 11 of its ownK053630 Levitronix Centrimag Primary ConsoleLevitronix, LLC · 2006
Showing 5 of 66 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 66 · See all- K973011BPX80 Bio-Pump (BPX80)Medtronic Bio-Medicus, Inc. · 1998 · cites it directly48descendants
- K020271Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100Levitronix, LLC · 2003 · 2 generations on21descendants
- K991783AB-180 XC System, Model AB-180XCCardiacassist, Inc. · 2000 · cites it directly13descendants
- K011835Cobe RevolutionCobe Cardiovascular, Inc. · 2002 · cites it directly12descendants
- K053630Levitronix Centrimag Primary ConsoleLevitronix, LLC · 2006 · 3 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K852698 | Bio Medicus Bio Pump Model BP-80 | Bio Medicus, Inc. | 1985 | — |
| +1 | K973011 | BPX80 Bio-Pump (BPX80) | Medtronic Bio-Medicus, Inc. | 1998 | — |
| +2 | K020271 | Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100 | Levitronix, LLC | 2003 | Class I |
| +1 | K991783 | AB-180 XC System, Model AB-180XC | Cardiacassist, Inc. | 2000 | — |
| +1 | K011835 | Cobe Revolution | Cobe Cardiovascular, Inc. | 2002 | 1 |
| +3 | K053630 | Levitronix Centrimag Primary Console | Levitronix, LLC | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 5 | 1 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2008 | 6 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 6 | 1 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 1 |
| 2017 | 1 | 0 |
| 2019 | 3 | 1 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (66)
See all 664 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 Class I)
No FDA recall names this device.
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 · 2 generations on · ◆ in the 2003 descendants bar of FIG. 11 Class I recall
- K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K183623LifeSPARC Pump, LifeSPARC ControllerCardiacassist, Inc. · 2019 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 12 Class I recalls
- K133598Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K973011 (Medtronic Bio-Medicus, Inc., 1998) has gone furthest, with 48 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 | — |
https://510kreport.com/device/K852698 · printed Nov 5, 2026
Cite this page
510(k) Report. “K852698: Bio Medicus Bio Pump Model BP-80.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K852698
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026