510(k) · Cleared
ClearedThoratec CentriMag Return (Arterial) Cannula Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thoratec Corporation · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on Sep 18, 2015 as substantially equivalent to K110980 (Levitronix, LLC, 2011) after a 46-day review. Its family tree reaches back 4 generations to 1988. 2 later devices descend from it.
- Decided
- Sep 18, 2015
- Review
- 46 days
- Class
- Class II
- Product code
- DWF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K880421 (1988). 6 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK880421 Descending Arch CannulaDlp, Inc. · 1988
- 3 generations backK991066 Madtronic DLP Arterial CannulaeMedtronic Vascular · 1999
- 2 generations backK031037 Eopa Elongated One-Piece Arterial Cannula and GuidewireMedtronic Perfusion Systems · 2003 · Recalled
- 1 generation backK110980 Centrimag Return Cannula KitLevitronix, LLC · 2011
- This deviceK152161 Thoratec CentriMag Return (Arterial) Cannula KitThoratec Corporation · 2015
- Descendant · cites it directly · 1 of its ownK200306 CentriMag Circulatory Support System, CentriMag Return (Arterial)…Abbott (Formerly Thoratec Corporation) · 2020
- Descendant · 2 generations on · 0 of its ownK234118 CentriMag™ Acute Circulatory Support SystemAbbott Medical · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K880421 | Descending Arch Cannula | Dlp, Inc. | 1988 | — |
| −3 | K991066 | Madtronic DLP Arterial Cannulae | Medtronic Vascular | 1999 | — |
| −2 | K031037 | Eopa Elongated One-Piece Arterial Cannula and Guidewire | Medtronic Perfusion Systems | 2003 | 6 |
| −1 | K110980 | Centrimag Return Cannula Kit | Levitronix, LLC | 2011 | — |
| 0 (this device) | K152161 | Thoratec CentriMag Return (Arterial) Cannula Kit | Thoratec Corporation | 2015 | — |
| +1 | K200306 | CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit… | Abbott (Formerly Thoratec Corporation) | 2020 | — |
| +2 | 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 |
|---|---|---|
| 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 14.7 · 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 |
|---|---|---|---|
| * | K110980 | Centrimag Return Cannula KitSummary page 4…ood, Drug and Cosmetic Act. C. Legally Marketed Predicate Device Thoratec CentriMag Return Cannula Kit (K110980) 31 July 2015 CONFIDENTIAL Page 25 of 110 Thoratec Corpor… | 2011 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200306 | CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag… | 2020 | 1 |
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 27 years and passes through 5 companies; a new generation was cleared every 8.1 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K200306 (Abbott (Formerly Thoratec Corporation), 2020) has gone furthest, with 1 descendant of its own.
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. 2015, 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 (Arterial) 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/K152161 · printed Nov 3, 2026
Cite this page
510(k) Report. “K152161: Thoratec CentriMag Return (Arterial) Cannula Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K152161
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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