510(k) · Cleared
ClearedSpiral Flow Peripheral Vascular Graft
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vascular Flow Technologies, Ltd. · DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Cleared on May 6, 2015 as substantially equivalent to K083169 (Tayside Flow Technologies Limited, 2009) and 1 other predicate after a 77-day review. Its family tree reaches back 4 generations to 1998.
- Decided
- May 6, 2015
- Review
- 77 days
- Class
- Class II
- Product code
- DSY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K983861 (1998). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK983861 Distaflo Bypass GraftImpra, Inc. · 1998 · Recalled
- 3 generations backK050049 Dynaflo Bypass GraftBard Peripheral Vascular, Inc. · 2005
- 2 generations backK083169 Eptfe Slftm Spiral Vascular GraftTayside Flow Technologies Limited · 2009
- 1 generation backK142062 Spiral Flow Peripheral Vascular GraftVascular Flow Technologies, Ltd. · 2014
- This deviceK150389 Spiral Flow Peripheral Vascular GraftVascular Flow Technologies, Ltd. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K983861 | Distaflo Bypass Graft | Impra, Inc. | 1998 | 2 |
| −3 | K050049 | Dynaflo Bypass Graft | Bard Peripheral Vascular, Inc. | 2005 | — |
| −2 | K083169 | Eptfe Slftm Spiral Vascular Graft | Tayside Flow Technologies Limited | 2009 | — |
| −1 | K142062 | Spiral Flow Peripheral Vascular Graft | Vascular Flow Technologies, Ltd. | 2014 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K083169 | Eptfe Slftm Spiral Vascular GraftSummary page 5…ce for implantation. Predicate Device: The modified device is substantially equivalent to the previously cleared Spiral Flow Peripheral Vascular Grafts, 510(k) numbers K083169 and K142062. Device Description: Vascular Flow Technologies’ (VFT) Spiral Flow™ Peripheral Vascular Graft is to be used in the… | 2009 |
| * | K142062 | Spiral Flow Peripheral Vascular GraftSummary page 5…ntation. Predicate Device: The modified device is substantially equivalent to the previously cleared Spiral Flow Peripheral Vascular Grafts, 510(k) numbers K083169 and K142062. Device Description: Vascular Flow Technologies’ (VFT) Spiral Flow™ Peripheral Vascular Graft is to be used in the bypass or re… | 2014 |
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 17 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 2 other devices also cite its predicate K083169.
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. 2015, 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 Spiral Flow Peripheral Vascular Grafts are indicated for use as vascular prostheses.
The device is intended for use in the bypass or 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.
ONLY trained and qualified physicians and/or surgeons, under the controlled conditions of a hospital operating theatre environment are indicated for use of this device for implantation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150389 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150389: Spiral Flow Peripheral 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/K150389
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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