Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Al.Chi.Mi.A. S.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) |
|---|---|---|---|---|---|
| K251320 | XTRA4 | Al.Chi.Mi.A. S.R.L | 2025-09-11 | 135 | 0 |
| DEN200063 | Kerasave | Al.Chi.Mi.A. S.R.L | 2022-05-02 | 578 | 0 |
| K162013 | Eusol-C | Al.Chi.Mi.A. S.R.L | 2016-09-15 | 56 | 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