Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Peca Labs · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K221628 | exGraft, exGraft Carbon | Peca Labs | 2022-08-04 | 59 | 0 |
| K202471 | exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular | Peca Labs | 2020-12-11 | 105 | 0 |
| K183613 | exGraft, exGraft Carbon | Peca Labs | 2019-04-22 | 117 | 0 |
| K180957 | exGraft, exGraft Carbon ePTFE Vascular Grafts | Peca Labs | 2018-08-21 | 131 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda