Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Fona S.R.L — 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) |
|---|---|---|---|---|---|
| K222274 | FONA XDC | Fona S.R.L | 2022-08-23 | 25 | 0 |
| K213579 | Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris | Fona S.R.L | 2022-03-02 | 112 | 0 |
| K212103 | StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 | Fona S.R.L | 2021-08-30 | 55 | 0 |
| K161131 | FONA Pan/Ceph | Fona S.R.L | 2016-11-03 | 196 | 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