510(k) · Cleared
Recalled · Class II · 2014Fem-Felx, Fex-Flex II Femoral Access 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 Mar 15, 2013 as substantially equivalent to K891576 (Research Medical, Inc., 1989) and 2 other predicates after a 143-day review. Its family tree reaches back 1 generation to 1989. 1 of the 6 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it. It has been recalled 4 times.
- Decided
- Mar 15, 2013
- Review
- 143 days
- Class
- Class II
- Product code
- DWF
- Recalls
- 4
- Predicates
- 3
Its longest line of descent runs back 1 generation to K891576 (1989). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK891576 Fem-Flex Femoral Access Cannulation SetResearch Medical, Inc. · 1989 · Recalled
- This deviceK123298 Fem-Felx, Fex-Flex II Femoral Access Cannula with Duraflo CoatingEdwards Lifesciences, LLC · 2013
- Descendant · cites it directly · 1 of its ownK140208 Ferm-Flex and Fem-Flex II ( Femoral Access Arterial Cannulae)…Edwards Lifesciences, LLC · 2014 · Recalled (Class I)
- Descendant · 2 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…cites it directly · 2014
Most influential descendants
Showing 2 of 2 · See all- K140208Ferm-Flex and Fem-Flex II ( Femoral Access Arterial Cannulae) Femtrak,Vfem, and Fem-FlexiiEdwards Lifesciences, LLC · 2014 · cites it directly1descendant
- K200358Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous…Edwards Lifesciences, LLC · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K891576 | Fem-Flex Femoral Access Cannulation Set | Research Medical, Inc. | 1989 | 2 |
| 0 (this device) | K123298 | Fem-Felx, Fex-Flex II Femoral Access Cannula with Duraflo Coating | Edwards Lifesciences, LLC | 2013 | — |
| +1 | K140208 | Ferm-Flex and Fem-Flex II ( Femoral Access Arterial Cannulae) Femtrak,Vfem… | Edwards Lifesciences, LLC | 2014 | Class I |
| +2 | K200358 | Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula… | Edwards Lifesciences, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K891576 | Fem-Flex Femoral Access Cannulation SetSummary page 1…opulmonary bypass vascular catheter, cannula or tubing Class 11 (21 CFR §870.4210). Predicate Devices * K891576, Cleared October 5, 1989 " K905312, Cleared January 15, 1991 " K033… | 1989 |
| * | K905312 | Duraflo II Heparin Treated Femoral Cannulae ModelsSummary page 1…Class 11 (21 CFR §870.4210). Predicate Devices * K891576, Cleared October 5, 1989 " K905312, Cleared January 15, 1991 " K033463, Cleared July 28, 2004 Device Description; The Edwards Femor… | 1991 |
| * | K033463 | Edwards Lifesciences Research Medical Pediatric Arterial CannulaeSummary page 1…* K891576, Cleared October 5, 1989 " K905312, Cleared January 15, 1991 " K033463, Cleared July 28, 2004 Device Description; The Edwards Femoral Access Arterial Cannulae with or without Duraflo® coating are wi… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140208 | Ferm-Flex and Fem-Flex II ( Femoral Access Arterial Cannulae) Femtrak,Vfem, and Fem-Flexii Class I | 2014 | 1 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 9, 2014 | Class II | Z-1466-2014 | Nonconforming Material/Component | Potential for separation of dilator tips. |
| Apr 9, 2014 | Class II | Z-1467-2014 | Nonconforming Material/Component | Potential for separation of dilator tips. |
| Aug 26, 2013 | Class II | Z-0135-2014 | Process control | Edwards Lifesciences is recalling two lots of Duraflo Cannulas due to reported complaints involving cracks in the t-connector of the devices which were confirmed during product evaluation. |
| Mar 14, 2013 | Class II | Z-1111-2013 | Packaging process control | Two unsealed pouches were found at an Edwards' distribution location in Japan. Incorrectly sealed pouches may result in a sterility barrier breach. |
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 · Cites it directly · ◆ in the 2014 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
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. 2013, 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?
Edwards Lifesciences Femoral Access Cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (≤ 6 hours) cardiopulmonary bypass. Vessel access (venous or arterial) is left to the discretion of the physician.
Femoral Access Cannula may be used in pediatric populations or adult populations based on flow rate requirements and individual patient anatomy. Please consult labeling to determine pressure drop related to flow rates.
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/K123298 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123298: Fem-Felx, Fex-Flex II Femoral Access 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/K123298
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