510(k) · Cleared
ClearedDLP Silicone Coronary Artery Ostial 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 Dec 7, 2023 as substantially equivalent to K141951 (Medtronic, Inc., 2014) after a 224-day review. Its family tree reaches back 4 generations to 1982.
- Decided
- Dec 7, 2023
- Review
- 224 days
- Class
- Class II
- Product code
- DWF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K821149 (1982). No later device cites it as a predicate yet.
- Root · 4 generations backK821149 Submission Coronary CannulaDlp, Inc. · 1982
- 3 generations backK034058 Spherical Tip Coronary Ostial Cannula, Model 30011Medtronic Vascular · 2004
- 2 generations backK131269 DLP Coronary Ostial Perfusion CannulaeMedtronic, Inc. · 2013 · Recalled
- 1 generation backK141951 DLP Silicone Coronary Artery Ostial CannulaeMedtronic, Inc. · 2014
- This deviceK231206 DLP Silicone Coronary Artery Ostial CannulaeMedtronic, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K821149 | Submission Coronary Cannula | Dlp, Inc. | 1982 | — |
| −3 | K034058 | Spherical Tip Coronary Ostial Cannula, Model 30011 | Medtronic Vascular | 2004 | — |
| −2 | K131269 | DLP Coronary Ostial Perfusion Cannulae | Medtronic, Inc. | 2013 | 1 |
| −1 | K141951 | DLP Silicone Coronary Artery Ostial Cannulae | Medtronic, Inc. | 2014 | — |
| 0 (this device) | K231206 | DLP Silicone Coronary Artery Ostial Cannulae | Medtronic, Inc. | 2023 | — |
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 |
|---|---|---|---|
| * | K141951 | DLP Silicone Coronary Artery Ostial CannulaeSummary page 4…ular catheter, cannula or tubing Regulation Number: 21 CFR 870.4210 Product Code: DWF Classification: Class II Predicate Device K141951 DLPTM Silicone Coronary Artery Ostial Cannulae, Models 30315, 30317, 30320… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 41 years and passes through 3 companies; a new generation was cleared every 9.4 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 1 other device also cites its predicate K141951.
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. 2023, 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 DLP Silicone Coronary Artery Ostial Cannulae, Models 30315, 30317, and 30320 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K231206 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231206: DLP Silicone Coronary Artery Ostial Cannulae.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231206
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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