510(k) · Cleared
ClearedA-Med Vascular Cannula, Models V24-10-08, V24-10-16, V24-10-32, V24-21-08, V24-21-44
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
A-Med Systems, Inc. · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on Dec 28, 1999 as substantially equivalent to K891576 (Research Medical, Inc., 1989) and 1 other predicate after a 239-day review. Its family tree reaches back 2 generations to 1983.
- Decided
- Dec 28, 1999
- Review
- 239 days
- Class
- Class II
- Product code
- DWF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K831769 (1983). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK831769 Various Cardiovascular Surgical DeviceResearch Industries Corp. · 1983 · Recalled
- 1 generation backK974259 Venous Flex II Peripheral and Intra-Operative Access Venous Return…Edwards Lifesciences Research Medical · 1998
- This deviceK991541 A-Med Vascular Cannula, Models V24-10-08, V24-10-16, V24-10-32…A-Med Systems, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K831769 | Various Cardiovascular Surgical Device | Research Industries Corp. | 1983 | 8 |
| −1 | K974259 | Venous Flex II Peripheral and Intra-Operative Access Venous Return Cannulae | Edwards Lifesciences Research Medical | 1998 | — |
| 0 (this device) | K991541 | A-Med Vascular Cannula, Models V24-10-08, V24-10-16, V24-10-32, V24-21-08… | A-Med Systems, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 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? (2)
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…Cannula, or Tubing” (21 CFR 870.4210) Predicate Devices: Claim of Substantial Equivalence of the A-Med Vascular Cannula is made to the Baxter/RMI FEM FLEX II Cannula (K891576, K974259) manufactured by Baxter Healthcare Corporation Baxter Research Medical Inc., 6864 South 300 West, Midvale, UT 84047 USA.… | 1989 |
| * | K974259 | Venous Flex II Peripheral and Intra-Operative Access Venous Return CannulaeSummary page 1…or Tubing” (21 CFR 870.4210) Predicate Devices: Claim of Substantial Equivalence of the A-Med Vascular Cannula is made to the Baxter/RMI FEM FLEX II Cannula (K891576, K974259) manufactured by Baxter Healthcare Corporation Baxter Research Medical Inc., 6864 South 300 West, Midvale, UT 84047 USA. Device… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 15.3 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 5 other devices also cite its predicate K891576.
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 A-Med Vascular Cannula is intended for intraoperative access to the arterial (i.e., aorta, femoral artery or pulmonary artery) or venous system, (i.e., femoral vein, right atrium) during procedures requiring arterial or venous access for short term extracorporeal support (less than six hours). Arterial or venous access is left to the discretion of the physician.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991541 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991541: A-Med Vascular Cannula, Models V24-10-08, V24-10-16, V24-10-32, V24-21-08, V24-21-44.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991541
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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