510(k) · Cleared
Recalled · Class I · 2021Bio-Console 560 Extracorporeal Blood Pumping Console
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · DWA Control, Pump Speed, Cardiopulmonary Bypass
Cleared on Jul 24, 2013 as substantially equivalent to K080824 (Medtronic Perfusion Systems, 2008) after a 27-day review. Its family tree reaches back 5 generations to 1992. 1 of the 15 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Jul 24, 2013
- Review
- 27 days
- Class
- Class II
- Product code
- DWA
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 5 generations to K915183 (1992). 12 ancestors in all, the oldest K871131 (1987). 2 later devices descend from it, 1 citing it directly. 1 of the 15 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK915183 Sarns 8000 Modular Perfusion System3M Health Care, Sarns · 1992 · Recalled
- 4 generations backK953901 Sarns 800 Roller Pump3M Health Care, Sarns · 1996
- 3 generations backK022947 Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System…Terumo Cardiovascular Systems Corp. · 2003 · Recalled
- 2 generations backK070286 Bio-Console, Model 560Medtronic · 2007
- 1 generation backK080824 Bio-Console 560Medtronic Perfusion Systems · 2008
- This deviceK131964 Bio-Console 560 Extracorporeal Blood Pumping ConsoleMedtronic, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK221491 Anivia SG1000 Pump ConsoleApmtd, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK230698 Anivia SG1000 Pump ConsoleApmtd, Inc. · 2023
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 |
|---|---|---|---|---|---|
| −5 | K915183 | Sarns 8000 Modular Perfusion System | 3M Health Care, Sarns | 1992 | 45 |
| −4 | K953901 | Sarns 800 Roller Pump | 3M Health Care, Sarns | 1996 | — |
| −3 | K022947 | Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System 1… | Terumo Cardiovascular Systems Corp. | 2003 | 150 |
| −2 | K070286 | Bio-Console, Model 560 | Medtronic | 2007 | — |
| −1 | K080824 | Bio-Console 560 | Medtronic Perfusion Systems | 2008 | — |
| 0 (this device) | K131964 | Bio-Console 560 Extracorporeal Blood Pumping Console | Medtronic, Inc. | 2013 | — |
| +1 | K221491 | Anivia SG1000 Pump Console | Apmtd, Inc. | 2023 | — |
| +2 | K230698 | Anivia SG1000 Pump Console | Apmtd, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K080824 | Bio-Console 560Summary page 1…DWA Name of Predicate Device: Bio-Console'o 560 Extracorporeal Blood Pumping Console (K080824) Device Description The Bio-Console® 560 Extracorporeal Blood Pumping Console is an electromechanical, software-contro… | 2008 |
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 |
|---|---|---|---|
| K221491 | Anivia SG1000 Pump Console | 2023 | 1 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 3, 2021 | Class I | Z-1313-2021 | Component change control | An electrical component within the system controller module of certain Bio-Console 560 devices may exhibit electrical failure causing the device to stop pumping. Issues observed include the pump stopping, the user interface going blank… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 4.2 years on median.
- 5 of the 12 ancestors have a recall of any class.
- Of its descendants, K221491 (Apmtd, Inc., 2023) has gone furthest, with 1 descendant 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. 2013, this device’s year, is highlighted.
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/K131964 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131964: Bio-Console 560 Extracorporeal Blood Pumping Console.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131964
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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