510(k) · Cleared
ClearedMedtronic Bio-Medicus Bio-Console Model 550M Pump Speed Controller
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Bio-Medicus, Inc. · DWA Control, Pump Speed, Cardiopulmonary Bypass
Cleared on Dec 23, 1994 after a 366-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 21 devices in its family, counting itself, has a Class I recall. 20 later devices descend from it.
- Decided
- Dec 23, 1994
- Review
- 366 days
- Class
- Class II
- Product code
- DWA
- Recalls
- None
- Predicates
- 0
20 later devices descend from it, 3 citing it directly. 1 of the 21 devices in this family, counting this one, has a Class I recall.
- This deviceK936091 Medtronic Bio-Medicus Bio-Console Model 550M Pump Speed ControllerMedtronic Bio-Medicus, Inc. · 1994
- Descendant · cites it directly · 9 of its ownK100631 Affiity CP Centrifugal Blood PumpMedtronic, Inc. · 2010
- Descendant · 2 generations on · 7 of its ownK111658 Affinity CP Centrifugal Bllod Pump with Carmeda Bioactive SurfaceMedtronic, Inc. · 2011
- Descendant · cites it directly · 7 of its ownK051303 Bio-Console, Model 560Medtronic Perfusion Systems · 2005 · Recalled
- Descendant · 2 generations on · 6 of its ownK070286 Bio-Console, Model 560Medtronic · 2007
- Descendant · 3 generations on · 5 of its ownK111972 Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm…Medtronic, Inc. · 2011
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K131964 Bio-Console 560 Extracorporeal Blood Pumping…4 generations on · 2013
Most influential descendants
Showing 5 of 20 · See all- K100631Affiity CP Centrifugal Blood PumpMedtronic, Inc. · 2010 · cites it directly9descendants
- K111658Affinity CP Centrifugal Bllod Pump with Carmeda Bioactive SurfaceMedtronic, Inc. · 2011 · 2 generations on7descendants
- K051303Bio-Console, Model 560Medtronic Perfusion Systems · 2005 · cites it directly7descendants
- K070286Bio-Console, Model 560Medtronic · 2007 · 2 generations on6descendants
- K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…Medtronic, Inc. · 2011 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K936091 | Medtronic Bio-Medicus Bio-Console Model 550M Pump Speed Controller | Medtronic Bio-Medicus, Inc. | 1994 | — |
| +1 | K100631 | Affiity CP Centrifugal Blood Pump | Medtronic, Inc. | 2010 | — |
| +2 | K111658 | Affinity CP Centrifugal Bllod Pump with Carmeda Bioactive Surface | Medtronic, Inc. | 2011 | — |
| +1 | K051303 | Bio-Console, Model 560 | Medtronic Perfusion Systems | 2005 | 1 |
| +2 | K070286 | Bio-Console, Model 560 | Medtronic | 2007 | — |
| +3 | K111972 | Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia… | Medtronic, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 1 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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.
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 DWA device
- #1 K221491 Anivia SG1000 Pump Consolescore 9.3 · 6 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? (20)
See all 203 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 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.
- K131964Bio-Console 560 Extracorporeal Blood Pumping ConsoleMedtronic, Inc. · 2013 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K100631 (Medtronic, Inc., 2010) has gone furthest, with 9 descendants of its own.
How does its category compare?
All DWA devicesDWA Control, Pump Speed, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DWA
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DWA
44in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DWA
1in 2022
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DWA
362in 2025
MAUDE reports naming product code DWA, 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 | 1 | — | 0 | 10 |
| 2008 | 3 | 44 | 0 | 10 |
| 2009 | 2 | — | 0 | 17 |
| 2010 | 2 | — | 1 | 110 |
| 2011 | 2 | — | 0 | 147 |
| 2012 | 0 | — | 3 | 102 |
| 2013 | 2 | — | 1 | 100 |
| 2014 | 0 | — | 0 | 98 |
| 2015 | 0 | — | 0 | 103 |
| 2016 | 0 | — | 0 | 109 |
| 2017 | 0 | — | 1 | 140 |
| 2018 | 0 | — | 0 | 200 |
| 2019 | 1 | — | 0 | 376 |
| 2020 | 2 | — | 0 | 146 |
| 2021 | 0 | — | 1 | 155 |
| 2022 | 0 | — | 1 (1) | 205 |
| 2023 | 2 | — | 0 | 438 |
| 2024 | 1 | — | 0 | 389 |
| 2025 | 0 | — | 0 | 362 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K936091 · printed Nov 4, 2026
Cite this page
510(k) Report. “K936091: Medtronic Bio-Medicus Bio-Console Model 550M Pump Speed Controller.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K936091
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026