510(k) · Cleared
ClearedEOPA 3D Arterial Cannula
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on Mar 20, 2015 as substantially equivalent to K061254 (Medtronic Perfusion Systems, 2006) after a 29-day review. Its family tree reaches back 5 generations to 1984. 1 later device descends from it.
- Decided
- Mar 20, 2015
- Review
- 29 days
- Class
- Class II
- Product code
- DWF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K840002 (1984). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK840002 Arterial Cannula Curved Beveled TipDlp, Inc. · 1984 · Recalled
- 4 generations backK013013 Medtronic DLP Arterial Cannula with 3D Tip - 22 FR.Medtronic Cardiac Surgical Products · 2001 · Recalled
- 3 generations backK033416 Select 3D Arterial Cannula with Carmeda Bioactive Surface and Select…Medtronic Perfusion Systems · 2003 · Recalled
- 2 generations backK043179 Select 3D Arterial CannulaMedtronic Perfusion Systems · 2005 · Recalled
- 1 generation backK061254 Eopa 3D Arterial Cannula, Models 78220,78222,78320,783222Medtronic Perfusion Systems · 2006
- This deviceK150422 EOPA 3D Arterial CannulaMedtronic, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK260195 Elongated One-Piece Arterial (EOPA) 3D™ Arterial CannulaeMedtronic, Inc. · 2026 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K260195Elongated One-Piece Arterial (EOPA) 3D™ Arterial CannulaeMedtronic, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K840002 | Arterial Cannula Curved Beveled Tip | Dlp, Inc. | 1984 | 3 |
| −4 | K013013 | Medtronic DLP Arterial Cannula with 3D Tip - 22 FR. | Medtronic Cardiac Surgical Products | 2001 | 1 |
| −3 | K033416 | Select 3D Arterial Cannula with Carmeda Bioactive Surface and Select Cap… | Medtronic Perfusion Systems | 2003 | 2 |
| −2 | K043179 | Select 3D Arterial Cannula | Medtronic Perfusion Systems | 2005 | 1 |
| −1 | K061254 | Eopa 3D Arterial Cannula, Models 78220,78222,78320,783222 | Medtronic Perfusion Systems | 2006 | — |
| 0 (this device) | K150422 | EOPA 3D Arterial Cannula | Medtronic, Inc. | 2015 | — |
| +1 | K260195 | Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae | Medtronic, Inc. | 2026 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K061254 | Eopa 3D Arterial Cannula, Models 78220,78222,78320,783222Summary page 5…ty and effectiveness of the device and the EOPA 3D® Arterial Cannula is substantially equivalent to the legally marketed predicate device, the EOPA 3D® Arterial Cannula (K061254). EOPA 3D Arterial Cannula KXXXXX Medtronic Confidential… | 2006 |
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 |
|---|---|---|---|
| K260195 | Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae | 2026 | 0 |
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 31 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 7 of the 8 ancestors have a recall of any class.
- Of its descendants, K260195 (Medtronic, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K061254.
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?
These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less)
cardiopulmonary bypass.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150422 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150422: EOPA 3D Arterial Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150422
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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