510(k) · Cleared
ClearedBPX80 Bio-Pump (BPX80)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Bio-Medicus, Inc. · KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Cleared on Feb 25, 1998 as substantially equivalent to K852698 (Bio Medicus, Inc., 1985) and 2 other predicates after a 196-day review. Its family tree reaches back 1 generation to 1985. 4 of the 52 devices in its family, counting itself, have a Class I recall. 48 later devices descend from it.
- Decided
- Feb 25, 1998
- Review
- 196 days
- Class
- Class II
- Product code
- KFM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K852698 (1985). 3 ancestors in all. 48 later devices descend from it, 10 citing it directly. 4 of the 52 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK852698 Bio Medicus Bio Pump Model BP-80Bio Medicus, Inc. · 1985
- This deviceK973011 BPX80 Bio-Pump (BPX80)Medtronic Bio-Medicus, Inc. · 1998
- Descendant · cites it directly · 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 · 2 generations on · 11 of its ownK053630 Levitronix Centrimag Primary ConsoleLevitronix, LLC · 2006
- Descendant · 2 generations on · 10 of its ownK081221 Levitronix Centrimag Primary Console, Thoratec Centrimag Primary…Levitronix, LLC · 2008
- Descendant · cites it directly · 9 of its ownK100631 Affiity CP Centrifugal Blood PumpMedtronic, Inc. · 2010
Showing 5 of 48 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 48 · See all- K020271Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100Levitronix, LLC · 2003 · cites it directly21descendants
- K991783AB-180 XC System, Model AB-180XCCardiacassist, Inc. · 2000 · cites it directly13descendants
- K053630Levitronix Centrimag Primary ConsoleLevitronix, LLC · 2006 · 2 generations on11descendants
- K081221Levitronix Centrimag Primary Console, Thoratec Centrimag Primary ConsoleLevitronix, LLC · 2008 · 2 generations on10descendants
- K100631Affiity CP Centrifugal Blood PumpMedtronic, Inc. · 2010 · cites it directly9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K852698 | Bio Medicus Bio Pump Model BP-80 | Bio Medicus, Inc. | 1985 | — |
| 0 (this device) | 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 |
| +1 | K991783 | AB-180 XC System, Model AB-180XC | Cardiacassist, Inc. | 2000 | — |
| +2 | K053630 | Levitronix Centrimag Primary Console | Levitronix, LLC | 2006 | — |
| +2 | K081221 | Levitronix Centrimag Primary Console, Thoratec Centrimag Primary Console | Levitronix, LLC | 2008 | — |
| +1 | K100631 | Affiity CP Centrifugal Blood Pump | Medtronic, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 1 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2008 | 5 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 6 | 1 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 1 |
| 2019 | 2 | 1 |
| 2020 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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? (3)
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 |
|---|---|---|---|
| * | K852698 | Bio Medicus Bio Pump Model BP-80Summary page 1…N NAME Centrifugal Blood Pump CLASSIFICATION NAME Non-roller type cardiopulmonary bypass blood pump (21 CFR - 870.4360) Medtronic Bio-Medicus, Inc. - BP-80 Bio-Pump® (K852698) Medtronic Cardiopulmonary - CBBP-80 Bio-Pump” (K852698, K891687 and K896978) Medtronic 510(k) Notification - BPX-80 Bio-Pump®… | 1985 |
| * | K891687 | Extracorporeal Circuit with Bio-Active SurfaceSummary page 1…e cardiopulmonary bypass blood pump (21 CFR - 870.4360) Medtronic Bio-Medicus, Inc. - BP-80 Bio-Pump® (K852698) Medtronic Cardiopulmonary - CBBP-80 Bio-Pump” (K852698, K891687 and K896978) Medtronic 510(k) Notification - BPX-80 Bio-Pump® Confidential Bio-Medicus, Inc. ) August 12, 1997 Page 9 === Page… | 1989 |
| * | K896978 | Closed Chest Support Circuit W/Bio-Active SurfaceSummary page 1…onary bypass blood pump (21 CFR - 870.4360) Medtronic Bio-Medicus, Inc. - BP-80 Bio-Pump® (K852698) Medtronic Cardiopulmonary - CBBP-80 Bio-Pump” (K852698, K891687 and K896978) Medtronic 510(k) Notification - BPX-80 Bio-Pump® Confidential Bio-Medicus, Inc. ) August 12, 1997 Page 9 DEVIC… | 1990 |
What descends from it? (48)
See all 4810 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020271 | Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100 Class I | 2003 | 21 |
| K991783 | AB-180 XC System, Model AB-180XC | 2000 | 13 |
| K100631 | Affiity CP Centrifugal Blood Pump | 2010 | 9 |
| K111658 | Affinity CP Centrifugal Bllod Pump with Carmeda Bioactive Surface | 2011 | 7 |
| K050109 | Trillium Biopump Plus, Model BPX80T | 2005 | 6 |
| K111972 | Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity… | 2011 | 5 |
| K191407 | Novalung System | 2020 | 3 |
| K992592 | A-Miniature Centrifugal Blood Pump System, Model CPB 2000 | 2000 | 2 |
| K080774 | Capiox SP Pump (with or Without X-Coating) | 2008 | 0 |
| K020529 | Large Centrifugal Blood Pump, Model CP-2 | 2002 | 0 |
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 · Cites it directly · ◆ in the 2003 descendants bar of FIG. 11 Class I recall
- K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K133598Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · 3 generations on · ◆ in the 2014 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
What does this lineage say?
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 Medtronic Bio-Medicus Bio-Pump centrifugal blood pump is indicated for use only with
the Medtronic Bio-Medicus Bio-Console 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973011 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973011: BPX80 Bio-Pump (BPX80).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973011
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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