510(k) · Cleared
Recalled · Class II · 2026Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae
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 Apr 23, 2026 as substantially equivalent to K150422 (Medtronic, Inc., 2015) after a 91-day review. Its family tree reaches back 6 generations to 1984. It has been recalled 2 times.
- Decided
- Apr 23, 2026
- Review
- 91 days
- Class
- Class II
- Product code
- DWF
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 6 generations to K840002 (1984). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK840002 Arterial Cannula Curved Beveled TipDlp, Inc. · 1984 · Recalled
- 5 generations backK013013 Medtronic DLP Arterial Cannula with 3D Tip - 22 FR.Medtronic Cardiac Surgical Products · 2001 · Recalled
- 4 generations backK033416 Select 3D Arterial Cannula with Carmeda Bioactive Surface and Select…Medtronic Perfusion Systems · 2003 · Recalled
- 3 generations backK043179 Select 3D Arterial CannulaMedtronic Perfusion Systems · 2005 · Recalled
- 2 generations backK061254 Eopa 3D Arterial Cannula, Models 78220,78222,78320,783222Medtronic Perfusion Systems · 2006
- 1 generation backK150422 EOPA 3D Arterial CannulaMedtronic, Inc. · 2015
- This deviceK260195 Elongated One-Piece Arterial (EOPA) 3D™ Arterial CannulaeMedtronic, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K840002 | Arterial Cannula Curved Beveled Tip | Dlp, Inc. | 1984 | 3 |
| −5 | K013013 | Medtronic DLP Arterial Cannula with 3D Tip - 22 FR. | Medtronic Cardiac Surgical Products | 2001 | 1 |
| −4 | K033416 | Select 3D Arterial Cannula with Carmeda Bioactive Surface and Select Cap… | Medtronic Perfusion Systems | 2003 | 2 |
| −3 | K043179 | Select 3D Arterial Cannula | Medtronic Perfusion Systems | 2005 | 1 |
| −2 | K061254 | Eopa 3D Arterial Cannula, Models 78220,78222,78320,783222 | Medtronic Perfusion Systems | 2006 | — |
| −1 | K150422 | EOPA 3D Arterial Cannula | Medtronic, Inc. | 2015 | — |
| 0 (this device) | K260195 | Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae | Medtronic, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 2001 | 2 | 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 |
|---|---|---|---|
| * | K150422 | EOPA 3D Arterial CannulaSummary page 5…: Class II Regulation Number: 21 CFR 870.4210 Product Code: DWF Predicate Device: EOPA 3D Arterial Cannula (K150422); Models 78220,78222,78320,78322 Device Description: The EOPA 3DTM Arterial Cannulae consist of… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 24, 2026 | Class II | Z-2811-2026 | Under Investigation by firm | Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures. |
| Jun 24, 2026 | Class II | Z-2810-2026 | Under Investigation by firm | Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 42 years and passes through 4 companies; a new generation was cleared every 8.7 years on median.
- 7 of the 9 ancestors have a recall of any class.
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. 2026, 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 arterial cannulae are indicated for perfusion of the ascending or descending aorta for conditions requiring CPB procedures up to 6 hours in duration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260195 · printed Nov 4, 2026
Cite this page
510(k) Report. “K260195: Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K260195
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026