510(k) · Cleared
Recalled · 2008Fem-Flex Femoral Access Cannulation Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Research Medical, Inc. · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on Oct 12, 1989 after a 206-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 of the 17 devices in its family, counting itself, have a Class I recall. 16 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 12, 1989
- Review
- 206 days
- Class
- Class II
- Product code
- DWF
- Recalls
- 2
- Predicates
- 0
16 later devices descend from it, 6 citing it directly. 3 of the 17 devices in this family, counting this one, have a Class I recall.
- This deviceK891576 Fem-Flex Femoral Access Cannulation SetResearch Medical, Inc. · 1989
- Descendant · cites it directly · 8 of its ownK052081 Remote Access Perfusion (Rap) Femoral Venous CannulaEstech, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 6 of its ownK060101 Estech Aortic Easy Flow CannulaEndoscopic Technologies, Inc. · 2006
- Descendant · 3 generations on · 3 of its ownK083111 Impella 5.0 Catheter FamilyAbiomed, Inc. · 2009 · Recalled
- Descendant · cites it directly · 3 of its ownK974259 Venous Flex II Peripheral and Intra-Operative Access Venous Return…Edwards Lifesciences Research Medical · 1998
- Descendant · cites it directly · 2 of its ownK123303 Femoral Access Venous CannulaeEdwards Lifesciences, LLC · 2013
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 16 · See all- K052081Remote Access Perfusion (Rap) Femoral Venous CannulaEstech, Inc. · 2005 · cites it directly8descendants
- K060101Estech Aortic Easy Flow CannulaEndoscopic Technologies, Inc. · 2006 · 2 generations on6descendants
- K083111Impella 5.0 Catheter FamilyAbiomed, Inc. · 2009 · 3 generations on3descendants
- K974259Venous Flex II Peripheral and Intra-Operative Access Venous Return CannulaeEdwards Lifesciences Research Medical · 1998 · cites it directly3descendants
- K123303Femoral Access Venous CannulaeEdwards Lifesciences, LLC · 2013 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K891576 | Fem-Flex Femoral Access Cannulation Set | Research Medical, Inc. | 1989 | — |
| +1 | K052081 | Remote Access Perfusion (Rap) Femoral Venous Cannula | Estech, Inc. | 2005 | 1 |
| +2 | K060101 | Estech Aortic Easy Flow Cannula | Endoscopic Technologies, Inc. | 2006 | — |
| +3 | K083111 | Impella 5.0 Catheter Family | Abiomed, Inc. | 2009 | 1 |
| +1 | K974259 | Venous Flex II Peripheral and Intra-Operative Access Venous Return Cannulae | Edwards Lifesciences Research Medical | 1998 | — |
| +1 | K123303 | Femoral Access Venous Cannulae | Edwards Lifesciences, LLC | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 1 |
| 2013 | 3 | 0 |
| 2014 | 2 | 2 |
| 2020 | 1 | 0 |
| 2025 | 2 | 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.
3 devices in this family have 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? (16)
See all 166 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052081 | Remote Access Perfusion (Rap) Femoral Venous Cannula | 2005 | 8 |
| K974259 | Venous Flex II Peripheral and Intra-Operative Access Venous Return Cannulae | 1998 | 3 |
| K123303 | Femoral Access Venous Cannulae | 2013 | 2 |
| K123298 | Fem-Felx, Fex-Flex II Femoral Access Cannula with Duraflo Coating | 2013 | 2 |
| K991541 | A-Med Vascular Cannula, Models V24-10-08, V24-10-16, V24-10-32, V24-21-08, V24-21-44 | 1999 | 0 |
| K972993 | Chase Femoral Access Cannulation Set | 1998 | 0 |
Has anything in its family been recalled? (3 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
- K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K133598Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · 5 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K052081 (Estech, Inc., 2005) has gone furthest, with 8 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 | — |
https://510kreport.com/device/K891576 · printed Nov 4, 2026
Cite this page
510(k) Report. “K891576: Fem-Flex Femoral Access Cannulation Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K891576
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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