510(k) · Cleared
ClearedBio-Console 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 May 7, 2008 as substantially equivalent to K070286 (Medtronic, 2007) after a 44-day review. Its family tree reaches back 4 generations to 1992. 1 of the 15 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- May 7, 2008
- Review
- 44 days
- Class
- Class II
- Product code
- DWA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K915183 (1992). 11 ancestors in all, the oldest K871131 (1987). 3 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 · 4 generations backK915183 Sarns 8000 Modular Perfusion System3M Health Care, Sarns · 1992 · Recalled
- 3 generations backK953901 Sarns 800 Roller Pump3M Health Care, Sarns · 1996
- 2 generations backK022947 Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System…Terumo Cardiovascular Systems Corp. · 2003 · Recalled
- 1 generation backK070286 Bio-Console, Model 560Medtronic · 2007
- This deviceK080824 Bio-Console 560Medtronic Perfusion Systems · 2008
- Descendant · cites it directly · 2 of its ownK131964 Bio-Console 560 Extracorporeal Blood Pumping ConsoleMedtronic, Inc. · 2013 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK221491 Anivia SG1000 Pump ConsoleApmtd, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK230698 Anivia SG1000 Pump ConsoleApmtd, Inc. · 2023
Class I recalls in this family
- K131964 Bio-Console 560 Extracorporeal Blood Pumping…cites it directly · 2013
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K915183 | Sarns 8000 Modular Perfusion System | 3M Health Care, Sarns | 1992 | 45 |
| −3 | K953901 | Sarns 800 Roller Pump | 3M Health Care, Sarns | 1996 | — |
| −2 | K022947 | Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System 1… | Terumo Cardiovascular Systems Corp. | 2003 | 150 |
| −1 | K070286 | Bio-Console, Model 560 | Medtronic | 2007 | — |
| 0 (this device) | K080824 | Bio-Console 560 | Medtronic Perfusion Systems | 2008 | — |
| +1 | K131964 | Bio-Console 560 Extracorporeal Blood Pumping Console | Medtronic, Inc. | 2013 | Class I |
| +2 | K221491 | Anivia SG1000 Pump Console | Apmtd, Inc. | 2023 | — |
| +3 | 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 |
|---|---|---|
| 2013 | 1 | 1 |
| 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 |
|---|---|---|---|
| * | K070286 | Bio-Console, Model 560Summary page 1…tion: Class II, 21 CFR 870.4380 Product Code: DWA Predicate Device: Medtronic Bio-Console® 560 510(k) No. K070286, Reg. No. 870.4380; Product Code: DWA Device Intended Use: The Medtronic centrifugal blood… | 2007 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131964 | Bio-Console 560 Extracorporeal Blood Pumping Console Class I | 2013 | 2 |
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 · Cites it directly · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
- 5 of the 11 ancestors have a recall of any class.
- Of its descendants, K131964 (Medtronic, Inc., 2013) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K070286.
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. 2008, 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/K080824 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080824: Bio-Console 560.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080824
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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