Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
A.T.S. Applicazione Tecnologie Speciali 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) |
|---|---|---|---|---|---|
| K250282 | Persona C HR | A.T.S. Applicazione Tecnologie Speciali S.R.L. | 2025-04-30 | 89 | 0 |
| K211777 | ARCO FP-S | A.T.S. Applicazione Tecnologie Speciali S.R.L. | 2021-08-13 | 65 | 0 |
| K211542 | PRIMO S | A.T.S. Applicazione Tecnologie Speciali S.R.L. | 2021-07-09 | 51 | 0 |
| K182086 | ARCO FP | A.T.S. Applicazione Tecnologie Speciali S.R.L. | 2019-08-20 | 383 | 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