510(k) · Cleared
ClearedVenaflo Ptfe Vascular Graft, Venaflo Graft with Carbon, Venaflo Vascular Graft
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Impra, Inc. · DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Cleared on May 7, 1998 after a 44-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- May 7, 1998
- Review
- 44 days
- Class
- Class II
- Product code
- DSY
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK981079 Venaflo Ptfe Vascular Graft, Venaflo Graft with Carbon, Venaflo…Impra, Inc. · 1998
- Descendant · cites it directly · 2 of its ownK052282 Venaflo II Vascular GraftBard Peripheral Vascular, Inc. · 2005
- Descendant · 2 generations on · 1 of its ownK094044 Spiral Laminar Flow Vascular Arteriovenous GraftTayside Flow Technologies Limited · 2010
- Descendant · 3 generations on · 0 of its ownK252277 Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)Vascular Flow Technologies Limited · 2025
Most influential descendants
Showing 3 of 3 · See all- K052282Venaflo II Vascular GraftBard Peripheral Vascular, Inc. · 2005 · cites it directly2descendants
- K094044Spiral Laminar Flow Vascular Arteriovenous GraftTayside Flow Technologies Limited · 2010 · 2 generations on1descendant
- K252277Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)Vascular Flow Technologies Limited · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981079 | Venaflo Ptfe Vascular Graft, Venaflo Graft with Carbon, Venaflo Vascular Graft | Impra, Inc. | 1998 | — |
| +1 | K052282 | Venaflo II Vascular Graft | Bard Peripheral Vascular, Inc. | 2005 | — |
| +2 | K094044 | Spiral Laminar Flow Vascular Arteriovenous Graft | Tayside Flow Technologies Limited | 2010 | — |
| +3 | K252277 | Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645) | Vascular Flow Technologies Limited | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2025 | 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 DSY? 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 DSY device
- #1 K252445 Fusion Bioline Vascular Graftscore 12.4 · 5 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 |
|---|---|---|---|
| * | — | Venaflo ePTFE Vascular Graft Named without a submission number | |
| * | — | IMPRA Carboflo Vascular Graft Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052282 | Venaflo II Vascular Graft | 2005 | 2 |
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?
- Of its descendants, K052282 (Bard Peripheral Vascular, Inc., 2005) has gone furthest, with 2 descendants of its own.
How does its category compare?
All DSY devicesDSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSY
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSY
160in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSY
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSY
151in 2025
MAUDE reports naming product code DSY, 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 | 1 | — | 0 | 120 |
| 2008 | 1 | — | 0 | 164 |
| 2009 | 5 | 73 | 2 | 193 |
| 2010 | 4 | 55 | 5 | 187 |
| 2011 | 1 | — | 0 | 165 |
| 2012 | 4 | 30 | 0 | 177 |
| 2013 | 5 | 69 | 1 | 207 |
| 2014 | 2 | — | 0 | 352 |
| 2015 | 1 | — | 0 | 460 |
| 2016 | 1 | — | 2 | 217 |
| 2017 | 3 | 269 | 0 | 193 |
| 2018 | 1 | — | 0 | 200 |
| 2019 | 1 | — | 0 | 232 |
| 2020 | 1 | — | 0 | 169 |
| 2021 | 2 | — | 0 | 168 |
| 2022 | 2 | — | 0 | 155 |
| 2023 | 2 | — | 0 | 149 |
| 2024 | 5 | 160 | 0 | 153 |
| 2025 | 2 | — | 1 | 151 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The Venaflo Grafts with Carbon are indicated for subcutaneous arteriovenous conduit for blood access only.
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/K981079 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981079: Venaflo Ptfe Vascular Graft, Venaflo Graft with Carbon, Venaflo Vascular Graft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981079
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