510(k) · Cleared
ClearedSwirlgraft Bypass and Vascular Access Grafts
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Veryan Medical Limited · DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Cleared on Nov 4, 2005 as substantially equivalent to K992832 (Sulzermedica, 1999) after a 169-day review. Its family tree reaches back 1 generation to 1999. 5 later devices descend from it.
- Decided
- Nov 4, 2005
- Review
- 169 days
- Class
- Class II
- Product code
- DSY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K992832 (1999). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK992832 Sulzer Vascutek Eptfe Vascular ProsthesisSulzermedica · 1999
- This deviceK051312 Swirlgraft Bypass and Vascular Access GraftsVeryan Medical Limited · 2005
- Descendant · cites it directly · 4 of its ownK083169 Eptfe Slftm Spiral Vascular GraftTayside Flow Technologies Limited · 2009
- Descendant · 2 generations on · 1 of its ownK142062 Spiral Flow Peripheral Vascular GraftVascular Flow Technologies, Ltd. · 2014
- Descendant · cites it directly · 1 of its ownK094044 Spiral Laminar Flow Vascular Arteriovenous GraftTayside Flow Technologies Limited · 2010
- Descendant · 2 generations on · 0 of its ownK252277 Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)Vascular Flow Technologies Limited · 2025
- Descendant · 2 generations on · 0 of its ownK150389 Spiral Flow Peripheral Vascular GraftVascular Flow Technologies, Ltd. · 2015
Most influential descendants
Showing 5 of 5 · See all- K083169Eptfe Slftm Spiral Vascular GraftTayside Flow Technologies Limited · 2009 · cites it directly4descendants
- K142062Spiral Flow Peripheral Vascular GraftVascular Flow Technologies, Ltd. · 2014 · 2 generations on1descendant
- K094044Spiral Laminar Flow Vascular Arteriovenous GraftTayside Flow Technologies Limited · 2010 · cites it directly1descendant
- K252277Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)Vascular Flow Technologies Limited · 2025 · 2 generations on0descendants
- K150389Spiral Flow Peripheral Vascular GraftVascular Flow Technologies, Ltd. · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992832 | Sulzer Vascutek Eptfe Vascular Prosthesis | Sulzermedica | 1999 | — |
| 0 (this device) | K051312 | Swirlgraft Bypass and Vascular Access Grafts | Veryan Medical Limited | 2005 | — |
| +1 | K083169 | Eptfe Slftm Spiral Vascular Graft | Tayside Flow Technologies Limited | 2009 | — |
| +2 | K142062 | Spiral Flow Peripheral Vascular Graft | Vascular Flow Technologies, Ltd. | 2014 | — |
| +1 | K094044 | Spiral Laminar Flow Vascular Arteriovenous Graft | Tayside Flow Technologies Limited | 2010 | — |
| +2 | K252277 | Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645) | Vascular Flow Technologies Limited | 2025 | — |
| +2 | K150389 | Spiral Flow Peripheral Vascular Graft | Vascular Flow Technologies, Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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? (1)
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 |
|---|---|---|---|
| * | K992832 | Sulzer Vascutek Eptfe Vascular ProsthesisSummary page 1…f Substantial Equivalence: The SwirlGraffTM Bypass and Vascular Access Grafts are substantially equivalent to Sulzer Medica's Sulzer Vascutek ePTFE Vascular Prosthesis (K992832). 8… | 1999 |
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? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 SwirlGraft Bypass Graft is intended for bypass or reconstruction of occluded or diseased peripheral arterial blood vessels.
The SwirlGraft Vascular Access Graft is intended for use as a subcutaneous arterio-venous conduit for vascular access.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051312 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051312: Swirlgraft Bypass and Vascular Access Grafts.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051312
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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