510(k) · Cleared
Recalled · Class II · 2024DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure Monitoring Extension Line Adapter, DLP Cardioplegia Adapter with Pressure Port
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 Oct 19, 2018 as substantially equivalent to K831591 (Dlp, Inc., 1983) after a 29-day review. Its family tree reaches back 1 generation to 1983. It has been recalled 2 times.
- Decided
- Oct 19, 2018
- Review
- 29 days
- Class
- Class II
- Product code
- DWF
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K831591 (1983). No later device cites it as a predicate yet.
- Root · 1 generation backK831591 Aortic Root Cannula W/Integral PressDlp, Inc. · 1983 · Recalled
- This deviceK182586 DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP…Medtronic, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K831591 | Aortic Root Cannula W/Integral Press | Dlp, Inc. | 1983 | 2 |
| 0 (this device) | K182586 | DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure… | Medtronic, Inc. | 2018 | — |
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 |
|---|---|---|---|
| * | K831591 | Aortic Root Cannula W/Integral PressSummary page 4…s vascular catheter, cannula, or tubing Regulation Number: 21 CFR 870.4210 Product Code: DWF Product Classification: Class II Name of Predicate Device K831591 DLP™ Aortic Root Cannula with Integral Pressure Monitoring Line and Extension Set D… | 1983 |
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 |
|---|---|---|---|---|
| Mar 19, 2024 | Class II | Z-1800-2024 | Process control | Potential for unsealed sterile packing. |
| Mar 19, 2024 | Class II | Z-1801-2024 | Process control | Potential for unsealed sterile packing. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 2 other devices also cite its predicate K831591.
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. 2018, 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 Aortic Root Cannula (Model 23009) is intended for short term use (six hours or less) in conjunction with cardiopulmonary bypass surgery for delivering cardioplegia solutions. The cannula may also be used to aspirate air from the aorta at the conclusion of the bypass procedure. The Model 23009 cannula may also be used to monitor pressure in the aorta. The DLP Aortic Root Cannula with Vent Line (Model 24009) is intended for use during…
Read the full statement (193 words)
The DLP Aortic Root Cannula (Model 23009) is intended for short term use (six hours or less) in conjunction with cardiopulmonary bypass surgery for delivering cardioplegia solutions. The cannula may also be used to aspirate air from the aorta at the conclusion of the bypass procedure. The Model 23009 cannula may also be used to monitor pressure in the aorta.
The DLP Aortic Root Cannula with Vent Line (Model 24009) is intended for use during cardiopulmonary bypass for delivering cardioplegia solutions and venting of the left heart for up to 6 hours. The cannula may be used to aspirate air from the aorta at the conclusion of the bypass procedure. The Model 24009 cannula may also be used to monitor pressure in the aorta.
The DLP Cardioplegia Adapter with Pressure Port (Model 15004) is intended for use in conjunction with the delivery of cardioplegia solution and to provide access for pressure monitoring for up to 6 hours.
The DLP Pressure Monitoring Extension Line Adapter (Models 25009 and 25010) is intended for extending the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery up to 6 hours or less.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182586 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182586: DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure Monitoring Extension Line Adapter, DLP Cardioplegia Adapter with Pressure Port.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182586
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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