510(k) · Cleared
Recalled · Class II · 2018Venous Drainage Cannula with Duraflo Coating
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifesciences, LLC · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on May 8, 2012 as substantially equivalent to K831769 (Research Industries Corp., 1983) and 2 other predicates after a 119-day review. Its family tree reaches back 1 generation to 1983. It has been recalled 4 times.
- Decided
- May 8, 2012
- Review
- 119 days
- Class
- Class II
- Product code
- DWF
- Recalls
- 4
- Predicates
- 3
Its longest line of descent runs back 1 generation to K831769 (1983). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK831769 Various Cardiovascular Surgical DeviceResearch Industries Corp. · 1983 · Recalled
- This deviceK120072 Venous Drainage Cannula with Duraflo CoatingEdwards Lifesciences, LLC · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K831769 | Various Cardiovascular Surgical Device | Research Industries Corp. | 1983 | 8 |
| 0 (this device) | K120072 | Venous Drainage Cannula with Duraflo Coating | Edwards Lifesciences, LLC | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2009 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K831769 | Various Cardiovascular Surgical DeviceSummary page 1…Bypass 21 CFR Part 870.4210, Product Code DWF, Class 11 Predicate Device: K831 769 - Venous Cannulae K033464 - Pediatric Venous Cannulae… | 1983 |
| * | K033464 | Edwards Lifesciences Research Medical Pediatric Venous Return CannulaeSummary page 1…21 CFR Part 870.4210, Product Code DWF, Class 11 Predicate Device: K831 769 - Venous Cannulae K033464 - Pediatric Venous Cannulae K092509 - Venous Cannulae Device Description: -- -… | 2004 |
| * | K092509 | Edwards Lifesciences Venous Return CannulaeSummary page 1…Predicate Device: K831 769 - Venous Cannulae K033464 - Pediatric Venous Cannulae K092509 - Venous Cannulae Device Description: -- - -Edwards- Lifesciences venous return cannulae are soft-cannulae-with-en… | 2009 |
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 7, 2018 | Class II | Z-3029-2018 | Labeling False and Misleading | The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life. |
| Mar 7, 2018 | Class II | Z-3030-2018 | Labeling False and Misleading | The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life. |
| Mar 7, 2018 | Class II | Z-3031-2018 | Labeling False and Misleading | The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life. |
| Nov 4, 2015 | Class II | Z-0398-2016 | Employee error | Edwards Lifesciences initiated a field action for the Thin-Flex Venous Cannula (Model TF292902A) because the connector size is incorrectly described in the Edwards product guide as 3/8 inch. The actual and correct connector size is 1/2… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 2 of the 3 ancestors have a recall of any class.
- 3 other devices also cite its predicate K831769.
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. 2012, 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?
Single Stage Venous Cannulae: Venous return cannulae are intended for cannula drainage from the right atrium or superior and inferior vena cava during extracorporeal circulation for a duration of 6 hours. Venous cannulae may be used in pediatric populations or adult populations based on flow rate requirements and patient anatomy. Please see labeling for maximum flow rate information. Extracorporeal circuit components with a Duraflo coating are intended…
Read the full statement (164 words)
Single Stage Venous Cannulae:
Venous return cannulae are intended for cannula drainage from the right atrium or superior and inferior vena cava during extracorporeal circulation for a duration of 6 hours.
Venous cannulae may be used in pediatric populations or adult populations based on flow rate requirements and patient anatomy. Please see labeling for maximum flow rate information.
Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.
Dual Stage Venous Cannulae:
Dual drainage venous return cannulae are indicated for venous cannulation so that extracorporeal circulation of the venous blood to a heart-lung machine may be achieved, for a duration of 6 hours.
Venous cannulae may be used in pediatric populations or adult populations based on flow rate requirements and patient anatomy. Please see labeling for maximum flow rate information.
Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120072 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120072: Venous Drainage Cannula with Duraflo Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120072
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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