510(k) · Cleared
Recalled · Class II · 2016Distaflo Bypass 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 Nov 24, 1998 after a 22-day review. The FDA summary names its predicate without a number. 7 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 24, 1998
- Review
- 22 days
- Class
- Class II
- Product code
- DSY
- Recalls
- 2
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK983861 Distaflo Bypass GraftImpra, Inc. · 1998
- Descendant · cites it directly · 5 of its ownK050049 Dynaflo Bypass GraftBard Peripheral Vascular, Inc. · 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 · 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
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K050049Dynaflo Bypass GraftBard Peripheral Vascular, Inc. · 2005 · cites it directly5descendants
- 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 · 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) | K983861 | Distaflo Bypass Graft | Impra, Inc. | 1998 | — |
| +1 | K050049 | Dynaflo Bypass Graft | Bard Peripheral Vascular, Inc. | 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 | — |
| +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 |
| 2009 | 2 | 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? (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 |
|---|---|---|---|
| * | — | IMPRA Carboflo® Vascular Graft Named without a submission number | |
| * | — | Venaflo® Vascular Graft Named without a submission number |
What descends from it? (7)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 5, 2016 | Class II | Z-0786-2016 | Error in labeling | Size mislabeling; the graft is a 6 mm diameter graft when the actual packaged product is an 8 mm graft. |
| Jan 5, 2016 | Class II | Z-0785-2016 | Error in labeling | Size mislabeling; the graft is labeled as a 6 mm diameter graft when the actual packaged product is an 8 mm graft. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K050049 (Bard Peripheral Vascular, Inc., 2005) has gone furthest, with 5 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?
Distaflo™ Bypass Grafts are intended for bypass or reconstruction of peripheral arterial blood vessels.
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/K983861 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983861: Distaflo Bypass Graft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983861
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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