510(k) · Cleared
Recalled · Class II · 2024DLP Coronary Ostial Perfusion 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 Jul 10, 2013 as substantially equivalent to K034058 (Medtronic Vascular, 2004) after a 68-day review. Its family tree reaches back 2 generations to 1982. 3 later devices descend from it. It has been recalled once.
- Decided
- Jul 10, 2013
- Review
- 68 days
- Class
- Class II
- Product code
- DWF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K821149 (1982). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK821149 Submission Coronary CannulaDlp, Inc. · 1982
- 1 generation backK034058 Spherical Tip Coronary Ostial Cannula, Model 30011Medtronic Vascular · 2004
- This deviceK131269 DLP Coronary Ostial Perfusion CannulaeMedtronic, Inc. · 2013
- Descendant · cites it directly · 2 of its ownK141951 DLP Silicone Coronary Artery Ostial CannulaeMedtronic, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK231206 DLP Silicone Coronary Artery Ostial CannulaeMedtronic, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK230960 DLP™ Silicone Coronary Artery Ostial CannulaeMedtronic, Inc. · 2023
Most influential descendants
Showing 3 of 3 · See all- K141951DLP Silicone Coronary Artery Ostial CannulaeMedtronic, Inc. · 2014 · cites it directly2descendants
- K231206DLP Silicone Coronary Artery Ostial CannulaeMedtronic, Inc. · 2023 · 2 generations on0descendants
- K230960DLP™ Silicone Coronary Artery Ostial CannulaeMedtronic, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K821149 | Submission Coronary Cannula | Dlp, Inc. | 1982 | — |
| −1 | K034058 | Spherical Tip Coronary Ostial Cannula, Model 30011 | Medtronic Vascular | 2004 | — |
| 0 (this device) | K131269 | DLP Coronary Ostial Perfusion Cannulae | Medtronic, Inc. | 2013 | — |
| +1 | K141951 | DLP Silicone Coronary Artery Ostial Cannulae | Medtronic, Inc. | 2014 | — |
| +2 | K231206 | DLP Silicone Coronary Artery Ostial Cannulae | Medtronic, Inc. | 2023 | — |
| +2 | K230960 | DLP™ Silicone Coronary Artery Ostial Cannulae | Medtronic, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K034058 | Spherical Tip Coronary Ostial Cannula, Model 30011Summary page 1…ypass vascular catheter, cannula, or tubing Regulation Number: 21 CFR 870.4210 Product Code: DWF Product Classification: Class 11 Predicate Devices K034058 Spherical Tip Coronary Ostial Cannulae Device Description These coronary Cannulae consist of basket-style tip… | 2004 |
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 |
|---|---|---|---|
| K141951 | DLP Silicone Coronary Artery Ostial Cannulae | 2014 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 19, 2024 | Class II | Z-1795-2024 | Process control | Potential for unsealed sterile packing. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 3 companies; a new generation was cleared every 21.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K141951 (Medtronic, Inc., 2014) has gone furthest, with 2 descendants 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. 2013, 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 conjunction with cardiopulmonary bypass surgery up to six hours or less for delivery of cardioplegia solutions directly to the coronary arteries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131269 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131269: DLP Coronary Ostial Perfusion Cannulae.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131269
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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