510(k) · Cleared
Recalled · 2010Bio-Console, Model 560
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Perfusion Systems · DWA Control, Pump Speed, Cardiopulmonary Bypass
Cleared on Jun 10, 2005 as substantially equivalent to K924205 (Medtronic Bio-Medicus, Inc., 1993) and 1 other predicate after a 22-day review. Its family tree reaches back 1 generation to 1993. 1 of the 10 devices in its family, counting itself, has a Class I recall. 7 later devices descend from it. It has been recalled once.
- Decided
- Jun 10, 2005
- Review
- 22 days
- Class
- Class II
- Product code
- DWA
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K924205 (1993). 2 ancestors in all. 7 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 · 1 generation backK924205 Medtronic Bio-Medicus Bio-Console Model 550Medtronic Bio-Medicus, Inc. · 1993
- This deviceK051303 Bio-Console, Model 560Medtronic Perfusion Systems · 2005
- Descendant · cites it directly · 6 of its ownK070286 Bio-Console, Model 560Medtronic · 2007
- Descendant · 2 generations on · 3 of its ownK080824 Bio-Console 560Medtronic Perfusion Systems · 2008
- Descendant · 3 generations on · 2 of its ownK131964 Bio-Console 560 Extracorporeal Blood Pumping ConsoleMedtronic, Inc. · 2013 · Recalled (Class I)
- Descendant · 4 generations on · 1 of its ownK221491 Anivia SG1000 Pump ConsoleApmtd, Inc. · 2023
- Descendant · 5 generations on · 0 of its ownK230698 Anivia SG1000 Pump ConsoleApmtd, Inc. · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K131964 Bio-Console 560 Extracorporeal Blood Pumping…3 generations on · 2013
Most influential descendants
Showing 5 of 7 · See all- K070286Bio-Console, Model 560Medtronic · 2007 · cites it directly6descendants
- K080824Bio-Console 560Medtronic Perfusion Systems · 2008 · 2 generations on3descendants
- K131964Bio-Console 560 Extracorporeal Blood Pumping ConsoleMedtronic, Inc. · 2013 · 3 generations on2descendants
- K221491Anivia SG1000 Pump ConsoleApmtd, Inc. · 2023 · 4 generations on1descendant
- K230698Anivia SG1000 Pump ConsoleApmtd, Inc. · 2023 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K924205 | Medtronic Bio-Medicus Bio-Console Model 550 | Medtronic Bio-Medicus, Inc. | 1993 | — |
| 0 (this device) | K051303 | Bio-Console, Model 560 | Medtronic Perfusion Systems | 2005 | — |
| +1 | K070286 | Bio-Console, Model 560 | Medtronic | 2007 | — |
| +2 | K080824 | Bio-Console 560 | Medtronic Perfusion Systems | 2008 | — |
| +3 | K131964 | Bio-Console 560 Extracorporeal Blood Pumping Console | Medtronic, Inc. | 2013 | Class I |
| +4 | K221491 | Anivia SG1000 Pump Console | Apmtd, Inc. | 2023 | — |
| +5 | K230698 | Anivia SG1000 Pump Console | Apmtd, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 1 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2023 | 2 | 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 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? (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 |
|---|---|---|---|
| * | K924205 | Medtronic Bio-Medicus Bio-Console Model 550Summary page 1…Cardiopulmonary bypass pump speed control Classification: Class II Predicate Devices: Bio-Console® 550 K924205 Bio-Console® 550M K936091 Device Description: The Bio-Console® 560… | 1993 |
| * | K936091 | Medtronic Bio-Medicus Bio-Console Model 550M Pump Speed ControllerSummary page 1…s II Predicate Devices: Bio-Console® 550 K924205 Bio-Console® 550M K936091 Device Description: The Bio-Console® 560 is a cardiopulmonary bypass pump speed controller. It is intended to pump blood throug… | 1994 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070286 | Bio-Console, Model 560 | 2007 | 6 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 21, 2010 | Not classified | Z-1939-2010 | Nonconforming Material/Component | The potential risks during the use of this power cord include electrical shock, delay in setup and therapy, interruption of therapy, device failure, and fires. Although Medtronic has received no reports of adverse events related to the… |
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 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K070286 (Medtronic, 2007) has gone furthest, with 6 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 | — |
What is it indicated for?
The Medtronic centrifugal blood pumping system is intended to pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass procedures (up to 6 hours).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051303 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051303: Bio-Console, Model 560.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051303
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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