510(k) · Cleared
ClearedLevitronix Centrimag Primary Console, Thoratec Centrimag Primary Console
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 Jun 19, 2008 as substantially equivalent to K020271 (Levitronix, LLC, 2003) and 1 other predicate after a 50-day review. Its family tree reaches back 4 generations to 1985. 2 of the 18 devices in its family, counting itself, have a Class I recall. 10 later devices descend from it.
- Decided
- Jun 19, 2008
- Review
- 50 days
- Class
- Class II
- Product code
- DWA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K852698 (1985). 7 ancestors in all. 10 later devices descend from it, 1 citing it directly. 2 of the 18 devices in this family, counting this one, have 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 backK053630 Levitronix Centrimag Primary ConsoleLevitronix, LLC · 2006
- This deviceK081221 Levitronix Centrimag Primary Console, Thoratec Centrimag Primary…Levitronix, LLC · 2008
- Descendant · cites it directly · 9 of its ownK083340 Levitronix Centrimag Primary Console; Thoratec Cantrimag Primary…Levitronix, LLC · 2008 · Recalled
- Descendant · 2 generations on · 4 of its ownK102129 Levitronix 2ND Generation Centrimag Primary Console, Levitronix…Levitronix, LLC · 2010
- Descendant · 3 generations on · 2 of its ownK191557 CentriMag Acute Circulatory Support SystemThoratec Corporation (Now Part of Abbott) · 2019
- Descendant · 2 generations on · 2 of its ownK110493 Tandemheart PumpCardiacassist, Inc. · 2011 · Recalled
- Descendant · 4 generations on · 1 of its ownK200306 CentriMag Circulatory Support System, CentriMag Return (Arterial)…Abbott (Formerly Thoratec Corporation) · 2020
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 10 · See all- K083340Levitronix Centrimag Primary Console; Thoratec Cantrimag Primary ConsoleLevitronix, LLC · 2008 · cites it directly9descendants
- K102129Levitronix 2ND Generation Centrimag Primary Console, Levitronix MonitorLevitronix, LLC · 2010 · 2 generations on4descendants
- K191557CentriMag Acute Circulatory Support SystemThoratec Corporation (Now Part of Abbott) · 2019 · 3 generations on2descendants
- K110493Tandemheart PumpCardiacassist, Inc. · 2011 · 2 generations on2descendants
- K200306CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag…Abbott (Formerly Thoratec Corporation) · 2020 · 4 generations on1descendant
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 | K053630 | Levitronix Centrimag Primary Console | Levitronix, LLC | 2006 | — |
| 0 (this device) | K081221 | Levitronix Centrimag Primary Console, Thoratec Centrimag Primary Console | Levitronix, LLC | 2008 | — |
| +1 | K083340 | Levitronix Centrimag Primary Console; Thoratec Cantrimag Primary Console | Levitronix, LLC | 2008 | 1 |
| +2 | K102129 | Levitronix 2ND Generation Centrimag Primary Console, Levitronix Monitor | Levitronix, LLC | 2010 | — |
| +3 | K191557 | CentriMag Acute Circulatory Support System | Thoratec Corporation (Now Part of Abbott) | 2019 | — |
| +2 | K110493 | Tandemheart Pump | Cardiacassist, Inc. | 2011 | 8 |
| +4 | K200306 | CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit… | Abbott (Formerly Thoratec Corporation) | 2020 | — |
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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2019 | 2 | 1 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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.
2 devices in this family have 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 |
|---|---|---|---|
| * | K020271 | Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100Summary page 1…nder section 514 of the Food, Drug and Cosmetic Act. C. Predicate Device: Levitronix CentriMag Console (K020271) Levitronix CentriMag Console Software Version 2.00 - special 510(k) (K053630) Levitronix LLC… | 2003 |
| * | K053630 | Levitronix Centrimag Primary ConsoleSummary page 1…Act. C. Predicate Device: Levitronix CentriMag Console (K020271) Levitronix CentriMag Console Software Version 2.00 - special 510(k) (K053630) Levitronix LLC Traditional 510(k): Device Modification Levitronix CentriMag® Extracorpor… | 2006 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083340 | Levitronix Centrimag Primary Console; Thoratec Cantrimag Primary Console | 2008 | 9 |
Has anything in its family been recalled? (2 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.
- K020271Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100Levitronix, LLC · 2003 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K183623LifeSPARC Pump, LifeSPARC ControllerCardiacassist, Inc. · 2019 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- 4 of the 7 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K083340 (Levitronix, LLC, 2008) has gone furthest, with 9 descendants of its own.
- 9 other devices also cite its predicate K020271.
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 Levitronix CentriMag Primary 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/K081221 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081221: Levitronix Centrimag Primary Console, Thoratec Centrimag Primary Console.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081221
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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