510(k) · Cleared
ClearedCentrimag Return Cannula Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Levitronix, LLC · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on Jun 20, 2011 as substantially equivalent to K031037 (Medtronic Perfusion Systems, 2003) after a 74-day review. Its family tree reaches back 3 generations to 1988. 3 later devices descend from it.
- Decided
- Jun 20, 2011
- Review
- 74 days
- Class
- Class II
- Product code
- DWF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K880421 (1988). 5 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK880421 Descending Arch CannulaDlp, Inc. · 1988
- 2 generations backK991066 Madtronic DLP Arterial CannulaeMedtronic Vascular · 1999
- 1 generation backK031037 Eopa Elongated One-Piece Arterial Cannula and GuidewireMedtronic Perfusion Systems · 2003 · Recalled
- This deviceK110980 Centrimag Return Cannula KitLevitronix, LLC · 2011
- Descendant · cites it directly · 2 of its ownK152161 Thoratec CentriMag Return (Arterial) Cannula KitThoratec Corporation · 2015
- Descendant · 2 generations on · 1 of its ownK200306 CentriMag Circulatory Support System, CentriMag Return (Arterial)…Abbott (Formerly Thoratec Corporation) · 2020
- Descendant · 3 generations on · 0 of its ownK234118 CentriMag™ Acute Circulatory Support SystemAbbott Medical · 2024
Most influential descendants
Showing 3 of 3 · See all- K152161Thoratec CentriMag Return (Arterial) Cannula KitThoratec Corporation · 2015 · cites it directly2descendants
- K200306CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag…Abbott (Formerly Thoratec Corporation) · 2020 · 2 generations on1descendant
- K234118CentriMag™ Acute Circulatory Support SystemAbbott Medical · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K880421 | Descending Arch Cannula | Dlp, Inc. | 1988 | — |
| −2 | K991066 | Madtronic DLP Arterial Cannulae | Medtronic Vascular | 1999 | — |
| −1 | K031037 | Eopa Elongated One-Piece Arterial Cannula and Guidewire | Medtronic Perfusion Systems | 2003 | 6 |
| 0 (this device) | K110980 | Centrimag Return Cannula Kit | Levitronix, LLC | 2011 | — |
| +1 | K152161 | Thoratec CentriMag Return (Arterial) Cannula Kit | Thoratec Corporation | 2015 | — |
| +2 | K200306 | CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit… | Abbott (Formerly Thoratec Corporation) | 2020 | — |
| +3 | K234118 | CentriMag™ Acute Circulatory Support System | Abbott Medical | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2020 | 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.
Planning a device in DWF? 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 DWF device
- #1 K251258 MC2™ Two-Stage Venous Cannula; MC2X™…score 14.6 · 8 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 |
|---|---|---|---|
| * | K031037 | Eopa Elongated One-Piece Arterial Cannula and GuidewireSummary page 1…Levitronix Device Predicate Predicate 510(k) CentriMag Return Cannula Kit Medtronic EOPA TM Elongate K031 037 one-piece Arterial Cannula and Guidewire (M… | 2003 |
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 |
|---|---|---|---|
| K152161 | Thoratec CentriMag Return (Arterial) Cannula Kit | 2015 | 2 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 8.1 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K152161 (Thoratec Corporation, 2015) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K031037.
How does its category compare?
All DWF devicesDWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · DWF
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DWF
89in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DWF
4in 2024
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · DWF
1,020in 2025
MAUDE reports naming product code DWF, 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 | 2 | — | 25 | 121 |
| 2008 | 6 | 95 | 25 | 126 |
| 2009 | 8 | 148 | 21 | 99 |
| 2010 | 3 | 62 | 26 | 197 |
| 2011 | 5 | 85 | 13 | 212 |
| 2012 | 10 | 110 | 37 | 233 |
| 2013 | 9 | 110 | 14 (1) | 238 |
| 2014 | 14 | 110 | 6 | 325 |
| 2015 | 9 | 46 | 3 (1) | 218 |
| 2016 | 3 | 32 | 3 | 144 |
| 2017 | 5 | 127 | 2 (1) | 101 |
| 2018 | 5 | 30 | 10 | 118 |
| 2019 | 3 | 120 | 2 | 179 |
| 2020 | 3 | 30 | 0 | 142 |
| 2021 | 5 | 358 | 3 | 162 |
| 2022 | 2 | — | 0 | 276 |
| 2023 | 2 | — | 0 | 470 |
| 2024 | 3 | 29 | 4 | 401 |
| 2025 | 4 | 89 | 0 | 1,020 |
| 2026 | 8 | 81 | 20 | — |
What is it indicated for?
The CentriMag Return Cannula is indicated for use as an arterial return cannula with an extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110980 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110980: Centrimag Return Cannula Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110980
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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