Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cefla S.C.R.L. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K080076 | RX DC X-RAY UNIT | Cefla S.C.R.L. | 2008-03-14 | 63 | 0 |
| K062897 | C-U2 | Cefla S.C.R.L. | 2006-12-14 | 78 | 0 |
| K061114 | WDS, SIZE 2 AND SIZE 2 | Cefla S.C.R.L. | 2006-06-06 | 46 | 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