Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
M&T 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) |
|---|---|---|---|---|---|
| K240604 | MTONE EVO (MTONE EVO) | M&T S.R.L. | 2024-09-20 | 200 | 0 |
| K192856 | MT One | M&T S.R.L. | 2020-04-24 | 203 | 0 |
| K191942 | MT One Diamond | M&T S.R.L. | 2019-10-17 | 87 | 0 |
| K172413 | MT ONE | M&T S.R.L. | 2017-10-06 | 57 | 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