510(k) · Cleared
Recalled · 2008Edwards Lifesciences Research Medical Pediatric Venous Return Cannulae
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 Jun 22, 2004 after a 235-day review. The FDA summary names its predicate without a number. 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 22, 2004
- Review
- 235 days
- Class
- Class II
- Product code
- DWF
- Recalls
- 2
- Predicates
- 0
4 later devices descend from it, 2 citing it directly. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- This deviceK033464 Edwards Lifesciences Research Medical Pediatric Venous Return CannulaeEdwards Lifesciences, LLC · 2004
- Descendant · cites it directly · 2 of its ownK123303 Femoral Access Venous CannulaeEdwards Lifesciences, LLC · 2013
- Descendant · 2 generations on · 1 of its ownK140208 Ferm-Flex and Fem-Flex II ( Femoral Access Arterial Cannulae)…Edwards Lifesciences, LLC · 2014 · Recalled (Class I)
- Descendant · 3 generations on · 0 of its ownK200358 Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous…Edwards Lifesciences, LLC · 2020
- Descendant · cites it directly · 0 of its ownK120072 Venous Drainage Cannula with Duraflo CoatingEdwards Lifesciences, LLC · 2012 · Recalled
Class I recalls in this family
- K140208 Ferm-Flex and Fem-Flex II ( Femoral Access…2 generations on · 2014
Most influential descendants
Showing 4 of 4 · See all- K123303Femoral Access Venous CannulaeEdwards Lifesciences, LLC · 2013 · cites it directly2descendants
- K140208Ferm-Flex and Fem-Flex II ( Femoral Access Arterial Cannulae) Femtrak,Vfem, and Fem-FlexiiEdwards Lifesciences, LLC · 2014 · 2 generations on1descendant
- K200358Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous…Edwards Lifesciences, LLC · 2020 · 3 generations on0descendants
- K120072Venous Drainage Cannula with Duraflo CoatingEdwards Lifesciences, LLC · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033464 | Edwards Lifesciences Research Medical Pediatric Venous Return Cannulae | Edwards Lifesciences, LLC | 2004 | — |
| +1 | K123303 | Femoral Access Venous Cannulae | Edwards Lifesciences, LLC | 2013 | — |
| +2 | K140208 | Ferm-Flex and Fem-Flex II ( Femoral Access Arterial Cannulae) Femtrak,Vfem… | Edwards Lifesciences, LLC | 2014 | Class I |
| +3 | K200358 | Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula… | Edwards Lifesciences, LLC | 2020 | — |
| +1 | K120072 | Venous Drainage Cannula with Duraflo Coating | Edwards Lifesciences, LLC | 2012 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 1 |
| 2020 | 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.
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? (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 |
|---|---|---|---|
| * | — | Research Industries' Various Cardiovascular Devices Named without a submission number | |
| * | — | Research Medical, Inc. Fern-Flex Femoral Access Cannulation Kit Named without a submission number | |
| * | — | Terumo L-Series 1968 Type Pediatric Venous Catheters Named without a submission number |
What descends from it? (4)
2 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 |
|---|---|---|---|---|
| Feb 25, 2008 | Not classified | Z-1894-2008 | Process control | Femoral Venous Cannula was color coded as an arterial cannula. This problem could result in a minor delay in the procedure. In the worst case, this product could be connected incorrectly during bypass, which would result in a more… |
| Feb 25, 2008 | Not classified | Z-1893-2008 | Process control | Femoral Venous Cannula was color coded as an arterial cannula. This problem could result in a minor delay in the procedure. In the worst case, this product could be connected incorrectly during bypass, which would result in a more… |
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.
- K140208Ferm-Flex and Fem-Flex II ( Femoral Access Arterial Cannulae) Femtrak,Vfem, and Fem-FlexiiEdwards Lifesciences, LLC · 2014 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- Of its descendants, K123303 (Edwards Lifesciences, LLC, 2013) 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.
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 Research Medical Dual Drainage Venous Return Cannulae is indicated for venous cannulation so that extracorporeal circulation of venous blood to a heart-lung machine may be achieved for a duration < 6 hours. Venous Cannulae in sizes 6 Fr. to 18 Fr. can be used in pediatric patient populations. The Research Medical Duraflo Heparin Treated Dual Drainage Venous Return Cannulae is indicated for venous cannulation so that extracorporeal circulation of…
Read the full statement (422 words)
The Research Medical Dual Drainage Venous Return Cannulae is indicated for venous cannulation so that extracorporeal circulation of venous blood to a heart-lung machine may be achieved for a duration < 6 hours. Venous Cannulae in sizes 6 Fr. to 18 Fr. can be used in pediatric patient populations.
The Research Medical Duraflo Heparin Treated Dual Drainage Venous Return Cannulae is indicated for venous cannulation so that extracorporeal circulation of venous blood to a heart-lung machine may be achieved for a duration < 6 hours. Venous Cannulae in sizes 6 Fr. to 18 Fr. can be used in pediatric patient populations. Extracorporeal circuit components with a Duraflo Treatment are indicated for use in cardiopulmonary surgery when a heparin-treated blood path is desired.
The Research Medical Venous Return Cannulae are intended for cannula drainage superior and inferior vena cave during extracorporeal circulation for a duration < 6 hours. Venous Cannulae in sizes 6 Fr. to 18 Fr. can be used in pediatric patient populations. NOTE: The Research Medical 40 Fr. and 46 Fr. Venous Return Cannulae are also intended for use in single cannula return of the right atrium.
The Research Medical Duraflo Heparin Treated Venous Return Cannulae are intended for cannula drainage superior and inferior vena cave during extracorporeal circulation for a duration < 6 hours. Venous Cannulae in sizes 6 Fr. to 18 Fr. can be used in pediatric patient populations. NOTE: The Research Medical 40 Fr. and 46 Fr. Venous Return Cannulae are also intended for use in single cannula return of the right atrium. Extracorporeal circuit components with a Duraflo Treatment are indicated for use in cardiopulmonary surgery when a heparin-treated blood path is desired.
The Research Medical FEM-FLEX Femoral Access Cannulae are intended for use in situations which require rapid femoral venous and arterial access for short term cardiopulmonary bypass. Venous and arterial access is left to the discretion of the physician for a duration < 6 hours. Femoral Cannulae in sizes 6 Fr. to 14 Fr. can be used in pediatric patient populations.
The Research Medical Duraflo Heparin Treated FEM-FLEX Femoral Access Cannulae are intended for use in situations which require rapid femoral venous and arterial access for short term cardiopulmonary bypass. Venous and arterial access is left to the discretion of the physician for a duration < 6 hours. Femoral Cannulae in sizes 6 Fr. to 14 Fr. can be used in pediatric patient populations. Extracorporeal circuit components with a Duraflo Treatment are indicated for use in cardiopulmonary surgery when a heparin-treated blood path is desired.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033464 · printed Nov 4, 2026
Cite this page
510(k) Report. “K033464: Edwards Lifesciences Research Medical Pediatric Venous Return Cannulae.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033464
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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