510(k) · Cleared
Recalled · 2011Edwards Lifesciences Research Medical Pediatric Arterial 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 Jul 28, 2004 after a 271-day review. The FDA summary names its predicate without a number. 1 of the 6 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it. It has been recalled once.
- Decided
- Jul 28, 2004
- Review
- 271 days
- Class
- Class II
- Product code
- DWF
- Recalls
- 1
- Predicates
- 0
5 later devices descend from it, 2 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- This deviceK033463 Edwards Lifesciences Research Medical Pediatric Arterial CannulaeEdwards Lifesciences, LLC · 2004
- Descendant · cites it directly · 2 of its ownK123298 Fem-Felx, Fex-Flex II Femoral Access Cannula with Duraflo CoatingEdwards Lifesciences, LLC · 2013 · Recalled
- 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 · cites it directly · 1 of its ownK123370 EZ Glide Aortic Cannula, Aortic Perfusion Cannula with Duraflo…Edwards Lifesciences, LLC · 2013 · Recalled
- Descendant · 2 generations on · 0 of its ownK233895 EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A…Edwards Lifesciences · 2024
- Descendant · 3 generations on · 0 of its ownK200358 Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous…Edwards Lifesciences, LLC · 2020
Class I recalls in this family
- K140208 Ferm-Flex and Fem-Flex II ( Femoral Access…2 generations on · 2014
Most influential descendants
Showing 5 of 5 · See all- K123298Fem-Felx, Fex-Flex II Femoral Access Cannula with Duraflo CoatingEdwards 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
- K123370EZ Glide Aortic Cannula, Aortic Perfusion Cannula with Duraflo Coating, Dispersion…Edwards Lifesciences, LLC · 2013 · cites it directly1descendant
- K233895EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA…Edwards Lifesciences · 2024 · 2 generations on0descendants
- K200358Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous…Edwards Lifesciences, LLC · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033463 | Edwards Lifesciences Research Medical Pediatric Arterial Cannulae | Edwards Lifesciences, LLC | 2004 | — |
| +1 | K123298 | Fem-Felx, Fex-Flex II Femoral Access Cannula with Duraflo Coating | Edwards Lifesciences, LLC | 2013 | 4 |
| +2 | K140208 | Ferm-Flex and Fem-Flex II ( Femoral Access Arterial Cannulae) Femtrak,Vfem… | Edwards Lifesciences, LLC | 2014 | Class I |
| +1 | K123370 | EZ Glide Aortic Cannula, Aortic Perfusion Cannula with Duraflo Coating… | Edwards Lifesciences, LLC | 2013 | 4 |
| +2 | K233895 | EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A… | Edwards Lifesciences | 2024 | — |
| +3 | K200358 | Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula… | Edwards Lifesciences, LLC | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 1 | 1 |
| 2020 | 1 | 0 |
| 2024 | 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 14.7 · 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 1964 Type Pediatric Aortic Cannulae Named without a submission number |
What descends from it? (5)
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 |
|---|---|---|---|---|
| Jan 21, 2011 | Not classified | Z-2196-2011 | Other | Bonding of the tip to the aortic cannula tubing may decline over time and may contribute to a drop in bond strength. Possible tip separation. |
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, K123298 (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?
(Models PEDA008SB, PEDA010SB, PEDA012SB, PEDA014SB, PEDA016SB, PAA010CB, PAA012CB, PAA014CB, PAA016CB, AA01SS, AA018C): The Edwards Lifesciences Research Medical Pediatric Aortic Perfusion Cannulae are indicated for perfusion of the aorta so that perfusion of the arteries via a heart-lung machine may take place. (Models APC018, APC018B) The Edwards Lifesciences Research Medical Pediatric Arterial Perfusion Cannulae are indicated for perfusion of the…
Read the full statement (128 words)
(Models PEDA008SB, PEDA010SB, PEDA012SB, PEDA014SB, PEDA016SB, PAA010CB, PAA012CB, PAA014CB, PAA016CB, AA01SS, AA018C): The Edwards Lifesciences Research Medical Pediatric Aortic Perfusion Cannulae are indicated for perfusion of the aorta so that perfusion of the arteries via a heart-lung machine may take place.
(Models APC018, APC018B) The Edwards Lifesciences Research Medical Pediatric Arterial Perfusion Cannulae are indicated for perfusion of the femoral artery during procedures requiring cardiopulmonary bypass where femoral artery cannulation is deemed appropriate.
(Models FEMIJ010A, FEMII1O2A, FEMII014A, FEMII008AT, FEMIJ010AT, FEMIJ012AT, FEMIL014AT): The Edwards Lifesciences Research Medical Pediatric Femoral Arterial Cannulae are indicated for use in situations which require rapid femoral arterial access for short term cardiopulmonary bypass.
Extracorporeal circuit components with a Duraflo Treatment are indicated 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/K033463 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033463: Edwards Lifesciences Research Medical Pediatric Arterial Cannulae.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033463
Report an extraction error
Are you the manufacturer?
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