510(k) · Cleared
ClearedexGraft, exGraft Carbon
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 4, 2022 as substantially equivalent to K202471 (Peca Labs, 2020) after a 59-day review. Its family tree reaches back 2 generations to 2001. 1 later device descends from it.
- Decided
- Aug 4, 2022
- Review
- 59 days
- Class
- Class II
- Product code
- DSY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K013250 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK013250 Gore-Tex Vascular Graft; Gore-Tex Stretch Vascular GraftW. L. Gore & Associates, Inc. · 2001
- 1 generation backK202471 exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular GraftPeca Labs · 2020
- This deviceK221628 exGraft, exGraft CarbonPeca Labs · 2022
- Descendant · cites it directly · 0 of its ownK233783 exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular GraftsPeca Labs, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K233783exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular GraftsPeca Labs, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K013250 | Gore-Tex Vascular Graft; Gore-Tex Stretch Vascular Graft | W. L. Gore & Associates, Inc. | 2001 | — |
| −1 | K202471 | exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft | Peca Labs | 2020 | — |
| 0 (this device) | K221628 | exGraft, exGraft Carbon | Peca Labs | 2022 | — |
| +1 | K233783 | exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts | Peca Labs, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (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 |
|---|---|---|---|
| * | K202471 | exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular GraftSummary page 4…ter Regulatory Class: Class II Product Code: DSY III. PREDICATE DEVICE exGraft and exGraft Carbon ePTFE Vascular Grafts [K202471] Impra Carboflo ePTFE Vascular Grafts [K004012 and K004011], Impra ePTFE Vascular Grafts [K954582 and K830543] are… | 2020 |
| † | K004012 | Impra Carboflo Eptfe Vascular Grafts | 2001 |
| † | K004011 | Impra Carboflo Vascular Graft, Impra Carboflo Vascular Grafts for a-V Access | 2001 |
| † | K954582 | Bard Expanded Ptfe Vascular Graft (Modification) | 1995 |
| † | K830543 | Vascular Graft Prosthesis Expanded Micr | 1983 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233783 | exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts | 2024 | 0 |
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 21 years and passes through 2 companies; a new generation was cleared every 19.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K233783 (Peca Labs, Inc., 2024) has gone furthest, with 0 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. 2022, 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.
exGraft and exGraft Carbon ePTFE Vascular Grafts are intended for use as vascular prostheses for replacement or bypass of diseased vessels in patients suffering occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures,
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221628 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221628: exGraft, exGraft Carbon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221628
Report an extraction error
Are you the manufacturer?
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