510(k) · Cleared
ClearedMeadox Exxcel Eptfe Vascular Graft
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meadox Medicals, Div. Boston Scientific Corp. · DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Cleared on Mar 17, 1997 as substantially equivalent to K791810 (Impra, Inc., 1979) and 1 other predicate after a 266-day review. Its family tree reaches back 2 generations to 1979. 12 later devices descend from it.
- Decided
- Mar 17, 1997
- Review
- 266 days
- Class
- Class II
- Product code
- DSY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K791810 (1979). 8 ancestors in all. 12 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK791810 Vascular Graft Prost. of Expanded PtfeImpra, Inc. · 1979
- 1 generation backK955460 Meadox Medicals, Inc., Expanded & Externally Supported Expanded Ptfe…Meadox Medicals, Div. Boston Scientific Corp. · 1996
- This deviceK962433 Meadox Exxcel Eptfe Vascular GraftMeadox Medicals, Div. Boston Scientific Corp. · 1997
- Descendant · cites it directly · 11 of its ownK052964 Exxcel and Exxcel Soft Eptfe Vascular Grafts, Microvel Double Velour…Boston Scientific Corp · 2006 · Recalled
- Descendant · 2 generations on · 7 of its ownK071778 Hero Vascular Access DeviceGraftcath, Inc. · 2008
- Descendant · 3 generations on · 6 of its ownK091491 Hero Vascular Access DeviceHemosphere, Inc. · 2009
- Descendant · 3 generations on · 5 of its ownK120006 Hero GraftHemosphere, Inc. · 2012
- Descendant · 3 generations on · 4 of its ownK121532 Hero GraftHemosphere, Inc. · 2012
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K052964Exxcel and Exxcel Soft Eptfe Vascular Grafts, Microvel Double Velour Knitted Vascular…Boston Scientific Corp · 2006 · cites it directly11descendants
- K071778Hero Vascular Access DeviceGraftcath, Inc. · 2008 · 2 generations on7descendants
- K091491Hero Vascular Access DeviceHemosphere, Inc. · 2009 · 3 generations on6descendants
- K120006Hero GraftHemosphere, Inc. · 2012 · 3 generations on5descendants
- K121532Hero GraftHemosphere, Inc. · 2012 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K791810 | Vascular Graft Prost. of Expanded Ptfe | Impra, Inc. | 1979 | — |
| −1 | K955460 | Meadox Medicals, Inc., Expanded & Externally Supported Expanded Ptfe Vascular… | Meadox Medicals, Div. Boston Scientific Corp. | 1996 | — |
| 0 (this device) | K962433 | Meadox Exxcel Eptfe Vascular Graft | Meadox Medicals, Div. Boston Scientific Corp. | 1997 | — |
| +1 | K052964 | Exxcel and Exxcel Soft Eptfe Vascular Grafts, Microvel Double Velour Knitted… | Boston Scientific Corp | 2006 | 3 |
| +2 | K071778 | Hero Vascular Access Device | Graftcath, Inc. | 2008 | — |
| +3 | K091491 | Hero Vascular Access Device | Hemosphere, Inc. | 2009 | — |
| +3 | K120006 | Hero Graft | Hemosphere, Inc. | 2012 | — |
| +3 | K121532 | Hero Graft | Hemosphere, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1982 | 1 | 0 |
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 1988 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 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 12.5 · 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K791810 | Vascular Graft Prost. of Expanded PtfeSummary page 1…ame - Vascular Graft Prosthesis (less than 6 mm) Vascular Graft Prosthesis (6 mm and greater) PREDICATE DEVICES: "Preamendment | IMPRA® Vascular Graft ‘VIMPRA, Inc. ) K791810 IMPRA® Vascular Graft "IMPRA, Inc. J K955460 | EXXCEL™ ePTFE Graft (6 - 10mm) | Meadox Medicals, Inc. K960766 EXXCEL™ ePTFE Graf… | 1979 |
| * | K955460 | Meadox Medicals, Inc., Expanded & Externally Supported Expanded Ptfe Vascular GraftSummary page 1…m) Vascular Graft Prosthesis (6 mm and greater) PREDICATE DEVICES: "Preamendment | IMPRA® Vascular Graft ‘VIMPRA, Inc. ) K791810 IMPRA® Vascular Graft "IMPRA, Inc. J K955460 | EXXCEL™ ePTFE Graft (6 - 10mm) | Meadox Medicals, Inc. K960766 EXXCEL™ ePTFE Graft (3-5mm) ' Meadox Medicals, Inc. DEVICE DESC… | 1996 |
| Kept off the family tree | K960766 | FDA’s K960766 is Meadox Medicals, Inc. Expanded Ptfe Vascular Graft Our OCR of the scanned summary read K960766, which FDA decided on Mar 19, 1997, after this device was decided (Mar 17, 1997), so it cannot be the predicate: a misreading, the summary’s own error, or a submission still pending at the time. Kept off the family tree. Summary page 1…S: "Preamendment | IMPRA® Vascular Graft ‘VIMPRA, Inc. ) K791810 IMPRA® Vascular Graft "IMPRA, Inc. J K955460 | EXXCEL™ ePTFE Graft (6 - 10mm) | Meadox Medicals, Inc. K960766 EXXCEL™ ePTFE Graft (3-5mm) ' Meadox Medicals, Inc. DEVICE DESCRIPTION: The unwrapped version of the MEADOX® EXXCEL"™ ¢PTFE Vasc… | 1997 |
What descends from it? (12)
See all 123 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 18 years and passes through 2 companies; a new generation was cleared every 16.6 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K052964 (Boston Scientific Corp, 2006) has gone furthest, with 11 descendants of its own.
- 4 other devices also cite its predicate K791810.
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 MEADOX® EXXCEL™ ePTFE Vascular Grafts are designed to repair or replace peripheral arteries and to provide vascular access. Mid-Flex grafts are specifically indicated for vascular access, as are Stepped grafts which are designed to reduce the risk of steal syndrome. Externally Supported Grafts are used where kinking and compression resistance are desired.
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/K962433 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962433: Meadox Exxcel Eptfe Vascular Graft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962433
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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