510(k) · Cleared
ClearedexGraft, exGraft Carbon ePTFE Vascular Grafts
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Peca Labs · DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Cleared on Aug 21, 2018 as substantially equivalent to K004011 (Impra, Inc., 2001) and 1 other predicate after a 131-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Aug 21, 2018
- Review
- 131 days
- Class
- Class II
- Product code
- DSY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K954582 (1995). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK954582 Bard Expanded Ptfe Vascular Graft (Modification)C.R. Bard, Inc. · 1995
- This deviceK180957 exGraft, exGraft Carbon ePTFE Vascular GraftsPeca Labs · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954582 | Bard Expanded Ptfe Vascular Graft (Modification) | C.R. Bard, Inc. | 1995 | — |
| 0 (this device) | K180957 | exGraft, exGraft Carbon ePTFE Vascular Grafts | Peca Labs | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 |
|---|---|---|---|
| * | K004011 | Impra Carboflo Vascular Graft, Impra Carboflo Vascular Grafts for a-V AccessSummary page 4…er Diameter Regulatory Class: Class II Product Code: DSY III. PREDICATE DEVICE Impra Carboflo ePTFE Vascular Grafts, K004011 and Impra ePTFE Vascular Grafts, K954582 The predicates have not been subject to a design-related recall. IV. DEVIC… | 2001 |
| * | K954582 | Bard Expanded Ptfe Vascular Graft (Modification)Summary page 4…Class II Product Code: DSY III. PREDICATE DEVICE Impra Carboflo ePTFE Vascular Grafts, K004011 and Impra ePTFE Vascular Grafts, K954582 The predicates have not been subject to a design-related recall. IV. DEVICE DESCRIPTION The exGraft and ex… | 1995 |
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?
- None of the 2 ancestors has a recall.
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. 2018, 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 exGraft and exGraft Carbon ePTFE Vascular Grafts are indicated for use as vascular prostheses.
The exGraft and exGraft Carbon ePTFE Vascular Grafts are intended for use as subcutaneous arteriovenous conduits for blood access, bypass, or reconstruction of peripheral arterial blood vessels.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180957 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180957: exGraft, exGraft Carbon ePTFE Vascular Grafts.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180957
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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