510(k) · Cleared
ClearedEptfe Slftm Spiral Vascular Graft
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tayside Flow Technologies Limited · DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Cleared on Mar 30, 2009 as substantially equivalent to K051312 (Veryan Medical Limited, 2005) and 3 other predicates after a 154-day review. Its family tree reaches back 2 generations to 1998. 4 later devices descend from it.
- Decided
- Mar 30, 2009
- Review
- 154 days
- Class
- Class II
- Product code
- DSY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K983861 (1998). 5 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK983861 Distaflo Bypass GraftImpra, Inc. · 1998 · Recalled
- 1 generation backK050049 Dynaflo Bypass GraftBard Peripheral Vascular, Inc. · 2005
- This deviceK083169 Eptfe Slftm Spiral Vascular GraftTayside Flow Technologies Limited · 2009
- Descendant · cites it directly · 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 · cites it directly · 0 of its ownK150389 Spiral Flow Peripheral Vascular GraftVascular Flow Technologies, Ltd. · 2015
Most influential descendants
Showing 4 of 4 · See all- K142062Spiral Flow Peripheral Vascular GraftVascular Flow Technologies, Ltd. · 2014 · cites it directly1descendant
- 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 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K983861 | Distaflo Bypass Graft | Impra, Inc. | 1998 | 2 |
| −1 | K050049 | Dynaflo Bypass Graft | Bard Peripheral Vascular, Inc. | 2005 | — |
| 0 (this device) | K083169 | Eptfe Slftm Spiral Vascular Graft | Tayside Flow Technologies Limited | 2009 | — |
| +1 | 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 | — |
| +1 | K150389 | Spiral Flow Peripheral Vascular Graft | Vascular Flow Technologies, Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K051312 | Swirlgraft Bypass and Vascular Access GraftsSummary page 2…for implantation. Summary of Substantial Equivalence: The ePTFE SLF TM Spiral Vascular Grafts are substantially equivalent to Veryan Medical Limited SwirlGraft Graft (K051312), Bard IMPRA DistaFlo® Bypass Graft (K983861), DynaFo TM Bypass Graft (K050049) and Vascutek PTFE Supported ePTFE Vascular Prosth… | 2005 |
| * | K983861 | Distaflo Bypass GraftSummary page 2…uivalence: The ePTFE SLF TM Spiral Vascular Grafts are substantially equivalent to Veryan Medical Limited SwirlGraft Graft (K051312), Bard IMPRA DistaFlo® Bypass Graft (K983861), DynaFo TM Bypass Graft (K050049) and Vascutek PTFE Supported ePTFE Vascular Prostheses (K043552) Device Description: The devi… | 1998 |
| * | K050049 | Dynaflo Bypass GraftSummary page 2…l Vascular Grafts are substantially equivalent to Veryan Medical Limited SwirlGraft Graft (K051312), Bard IMPRA DistaFlo® Bypass Graft (K983861), DynaFo TM Bypass Graft (K050049) and Vascutek PTFE Supported ePTFE Vascular Prostheses (K043552) Device Description: The device is a vascular graft which has a… | 2005 |
| * | K043552 | Vascutek Ptfe Supported Eptfe Vascular ProsthesesSummary page 2…Limited SwirlGraft Graft (K051312), Bard IMPRA DistaFlo® Bypass Graft (K983861), DynaFo TM Bypass Graft (K050049) and Vascutek PTFE Supported ePTFE Vascular Prostheses (K043552) Device Description: The device is a vascular graft which has a specially designed section intended to induce spiral laminar fl… | 2005 |
What descends from it? (4)
3 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?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 6.2 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K142062 (Vascular Flow Technologies, Ltd., 2014) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K051312.
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. 2009, this device’s year, is highlighted.
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 ePTFE SLF™ Spiral Vascular Graft is indicated for ruse as a vascular prosthesis. It is intended for use in the bypass of reconstruction of occluded or diseased peripheral arterial blood vessels above or below the knee. Graft configurations are intended for use as arterial conduits for bypass, or reconstruction of peripheral arterial blood vessels.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083169 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083169: Eptfe Slftm Spiral Vascular Graft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083169
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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