510(k) · Cleared
ClearedBio-Console, Model 560
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic · DWA Control, Pump Speed, Cardiopulmonary Bypass
Cleared on May 22, 2007 as substantially equivalent to K051303 (Medtronic Perfusion Systems, 2005) and 2 other predicates after a 113-day review. Its family tree reaches back 3 generations to 1992. 1 of the 17 devices in its family, counting itself, has a Class I recall. 6 later devices descend from it.
- Decided
- May 22, 2007
- Review
- 113 days
- Class
- Class II
- Product code
- DWA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K915183 (1992). 10 ancestors in all, the oldest K871131 (1987). 6 later devices descend from it, 3 citing it directly. 1 of the 17 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK915183 Sarns 8000 Modular Perfusion System3M Health Care, Sarns · 1992 · Recalled
- 2 generations backK953901 Sarns 800 Roller Pump3M Health Care, Sarns · 1996
- 1 generation backK022947 Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System…Terumo Cardiovascular Systems Corp. · 2003 · Recalled
- This deviceK070286 Bio-Console, Model 560Medtronic · 2007
- Descendant · cites it directly · 3 of its ownK080824 Bio-Console 560Medtronic Perfusion Systems · 2008
- Descendant · 2 generations on · 2 of its ownK131964 Bio-Console 560 Extracorporeal Blood Pumping ConsoleMedtronic, Inc. · 2013 · Recalled (Class I)
- Descendant · 3 generations on · 1 of its ownK221491 Anivia SG1000 Pump ConsoleApmtd, Inc. · 2023
- Descendant · 4 generations on · 0 of its ownK230698 Anivia SG1000 Pump ConsoleApmtd, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK150530 Level Sensor, Level Sensor TapeMedtronic, Inc. · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K131964 Bio-Console 560 Extracorporeal Blood Pumping…2 generations on · 2013
Most influential descendants
Showing 5 of 6 · See all- K080824Bio-Console 560Medtronic Perfusion Systems · 2008 · cites it directly3descendants
- K131964Bio-Console 560 Extracorporeal Blood Pumping ConsoleMedtronic, Inc. · 2013 · 2 generations on2descendants
- K221491Anivia SG1000 Pump ConsoleApmtd, Inc. · 2023 · 3 generations on1descendant
- K230698Anivia SG1000 Pump ConsoleApmtd, Inc. · 2023 · 4 generations on0descendants
- K150530Level Sensor, Level Sensor TapeMedtronic, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K915183 | Sarns 8000 Modular Perfusion System | 3M Health Care, Sarns | 1992 | 45 |
| −2 | K953901 | Sarns 800 Roller Pump | 3M Health Care, Sarns | 1996 | — |
| −1 | K022947 | Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System 1… | Terumo Cardiovascular Systems Corp. | 2003 | 150 |
| 0 (this device) | K070286 | Bio-Console, Model 560 | Medtronic | 2007 | — |
| +1 | K080824 | Bio-Console 560 | Medtronic Perfusion Systems | 2008 | — |
| +2 | K131964 | Bio-Console 560 Extracorporeal Blood Pumping Console | Medtronic, Inc. | 2013 | Class I |
| +3 | K221491 | Anivia SG1000 Pump Console | Apmtd, Inc. | 2023 | — |
| +4 | K230698 | Anivia SG1000 Pump Console | Apmtd, Inc. | 2023 | — |
| +1 | K150530 | Level Sensor, Level Sensor Tape | Medtronic, Inc. | 2015 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K051303 | Bio-Console, Model 560 | 2005 |
| * | K022947 | Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System 1 (220/240 Volt…Summary page 1….4380 Product Code: DWA Classification: Class LI Predicate Devices: Medtronic Bio-Console® 560 (KO5 1303) Terumno System 1 (K022947) Rocky Mountain Research, Inc. Automatic Tubing Clamp System (K961364) Device Description: The Bio-Console® 560 is an ex… | 2003 |
| * | K961364 | Automatic Tubing Clamp System (Atc)Summary page 1…I Predicate Devices: Medtronic Bio-Console® 560 (KO5 1303) Terumno System 1 (K022947) Rocky Mountain Research, Inc. Automatic Tubing Clamp System (K961364) Device Description: The Bio-Console® 560 is an extracorporeal blood pumping console consisting of a Base Unit with a display a… | 1996 |
What descends from it? (6)
3 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 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- 5 of the 10 ancestors have a recall of any class.
- Of its descendants, K080824 (Medtronic Perfusion Systems, 2008) has gone furthest, with 3 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. 2007, 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/K070286 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070286: Bio-Console, Model 560.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070286
Report an extraction error
Are you the manufacturer?
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