510(k) · Cleared
Recalled · Class II · 2018Levitronix, Thoratec Centrimag Back-UP Consoles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Levitronix, LLC · DWA Control, Pump Speed, Cardiopulmonary Bypass
Cleared on Jan 15, 2009 as substantially equivalent to K051209 (Levitronix, LLC, 2005) after a 13-day review. Its family tree reaches back 4 generations to 1985. 1 of the 9 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled once.
- Decided
- Jan 15, 2009
- Review
- 13 days
- Class
- Class II
- Product code
- DWA
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K852698 (1985). 7 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 9 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK852698 Bio Medicus Bio Pump Model BP-80Bio Medicus, Inc. · 1985
- 3 generations backK973011 BPX80 Bio-Pump (BPX80)Medtronic Bio-Medicus, Inc. · 1998
- 2 generations backK020271 Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100Levitronix, LLC · 2003 · Recalled (Class I)
- 1 generation backK051209 Levitronix Centrimag Back-UP ConsoleLevitronix, LLC · 2005 · Recalled
- This deviceK090004 Levitronix, Thoratec Centrimag Back-UP ConsolesLevitronix, LLC · 2009
- Descendant · cites it directly · 0 of its ownK093832 Levitronix Centrimag Primary and Backup ConsolesLevitronix, LLC · 2010
Class I recalls in this family
- K020271 Levitronix Centrimag Extracorporeal Blood…2 generations back · 2003
Most influential descendants
Showing 1 of 1 · See all- K093832Levitronix Centrimag Primary and Backup ConsolesLevitronix, LLC · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K852698 | Bio Medicus Bio Pump Model BP-80 | Bio Medicus, Inc. | 1985 | — |
| −3 | K973011 | BPX80 Bio-Pump (BPX80) | Medtronic Bio-Medicus, Inc. | 1998 | — |
| −2 | K020271 | Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100 | Levitronix, LLC | 2003 | Class I |
| −1 | K051209 | Levitronix Centrimag Back-UP Console | Levitronix, LLC | 2005 | 1 |
| 0 (this device) | K090004 | Levitronix, Thoratec Centrimag Back-UP Consoles | Levitronix, LLC | 2009 | — |
| +1 | K093832 | Levitronix Centrimag Primary and Backup Consoles | Levitronix, LLC | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 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 |
|---|---|---|---|
| * | K051209 | Levitronix Centrimag Back-UP ConsoleSummary page 1…Food, Drug and -Cosmetic Act. C. Predicate Device: Levitronix CentriMag Back-Up Console Software Version 1.01 - 510(k) (K051209) Levitronix LLC Special 610(k,: Device Modification -,centriMag Back-UpCon… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093832 | Levitronix Centrimag Primary and Backup Consoles | 2010 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 5, 2018 | Class II | Z-0103-2019 | Device Design | Reports of circulatory support system motor stopping. Motor stop can be attributed to a break of a wire or short circuit between wires within the electrical cable where the cable exits the motor cable bend protection. |
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.
- K020271Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100Levitronix, LLC · 2003 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- 5 of the 7 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K093832 (Levitronix, LLC, 2010) has gone furthest, with 0 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. 2009, 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 Levitronix CentriMag Back-Up Console is indicated for use with the Levitronix CentriMag Extracorporeal Blood Pumping System. The Levitronix CentriMag Extracorporeal Blood Pumping System is indicated to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090004 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090004: Levitronix, Thoratec Centrimag Back-UP Consoles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090004
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