510(k) · Cleared
ClearedVascutek Graft Sizer Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carbomedics, Inc. · DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Cleared on Mar 7, 1996 as substantially equivalent to K854431 (Meadox Medicals, Div. Boston Scientific Corp., 1986) after a 91-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Mar 7, 1996
- Review
- 91 days
- Class
- Class II
- Product code
- DSY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K854431 (1986). No later device cites it as a predicate yet.
- Root · 1 generation backK854431 Meadox Medicals Inc. Graft SizerMeadox Medicals, Div. Boston Scientific Corp. · 1986
- This deviceK955588 Vascutek Graft Sizer SetCarbomedics, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K854431 | Meadox Medicals Inc. Graft Sizer | Meadox Medicals, Div. Boston Scientific Corp. | 1986 | — |
| 0 (this device) | K955588 | Vascutek Graft Sizer Set | Carbomedics, Inc. | 1996 | — |
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 |
|---|---|---|---|
| * | K854431 | Meadox Medicals Inc. Graft SizerSummary page 1…tended use, composition, design, and function to the Meadox Graft Sizer manufactured by Meadox Medical, Inc. Marketing clearance was granted by the FDA for 510(k) number K854431 on May 7, 1988, for the Meadox Graft Sizer. Contact Person: Edward E. Newton Regulatory Affairs Specialist CarboMedics, Inc. 1… | 1986 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K854431.
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 Vascutek Graft Sizer Set is designed to aid the surgeon in accurately matching the size of vascular graft to the artery. The size of graft to be selected will correspond with the number indicated on the graft sizer which best fits the outside of the vessel.
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/K955588 · printed Nov 6, 2026
Cite this page
510(k) Report. “K955588: Vascutek Graft Sizer Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955588
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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