510(k) · Cleared
Recalled · Class II · 2017Aortic Root Cannula W/Integral Press
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dlp, Inc. · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on Jun 30, 1983 after a 44-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 5 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 30, 1983
- Review
- 44 days
- Class
- Class II
- Product code
- DWF
- Recalls
- 2
- Predicates
- 0
4 later devices descend from it, 3 citing it directly. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- This deviceK831591 Aortic Root Cannula W/Integral PressDlp, Inc. · 1983
- Descendant · cites it directly · 1 of its ownK040173 Pediatric Aortic Root CannulaMedtronic Perfusion Systems · 2004
- Descendant · cites it directly · 0 of its ownK182586 DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP…Medtronic, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 0 of its ownK100274 Miar (Minimally Invasive Aortic Root) Cannula with Flow-Guard…Medtronic, Inc. · 2010 · Recalled (Class I)
- Descendant · cites it directly · 0 of its ownK012143 24 FR. Left Heart Vent Catheter with Pressure Monitoring Line, Model…Medtronic Cardiac Surgical Products · 2001
Class I recalls in this family
- K100274 Miar (Minimally Invasive Aortic Root) Cannula…2 generations on · 2010
Most influential descendants
Showing 4 of 4 · See all- K040173Pediatric Aortic Root CannulaMedtronic Perfusion Systems · 2004 · cites it directly1descendant
- K182586DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure Monitoring…Medtronic, Inc. · 2018 · cites it directly0descendants
- K100274Miar (Minimally Invasive Aortic Root) Cannula with Flow-Guard, Models 11012L and 11014LMedtronic, Inc. · 2010 · 2 generations on0descendants
- K01214324 FR. Left Heart Vent Catheter with Pressure Monitoring Line, Model 12524Medtronic Cardiac Surgical Products · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K831591 | Aortic Root Cannula W/Integral Press | Dlp, Inc. | 1983 | — |
| +1 | K040173 | Pediatric Aortic Root Cannula | Medtronic Perfusion Systems | 2004 | — |
| +1 | K182586 | DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure… | Medtronic, Inc. | 2018 | 2 |
| +2 | K100274 | Miar (Minimally Invasive Aortic Root) Cannula with Flow-Guard, Models 11012L… | Medtronic, Inc. | 2010 | Class I |
| +1 | K012143 | 24 FR. Left Heart Vent Catheter with Pressure Monitoring Line, Model 12524 | Medtronic Cardiac Surgical Products | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2010 | 1 | 1 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 22, 2017 | Class II | Z-2767-2017 | Packaging process control | Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected. |
| Jun 22, 2017 | Class II | Z-2766-2017 | Packaging process control | Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K100274Miar (Minimally Invasive Aortic Root) Cannula with Flow-Guard, Models 11012L and 11014LMedtronic, Inc. · 2010 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K040173 (Medtronic Perfusion Systems, 2004) has gone furthest, with 1 descendant 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.
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 | — |
https://510kreport.com/device/K831591 · printed Nov 4, 2026
Cite this page
510(k) Report. “K831591: Aortic Root Cannula W/Integral Press.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K831591
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026