Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tecnimed S.R.L. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
217 daysmedian FDA review time
617 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K160680 | VisioFocus Mini, VisioFocus Smart | Tecnimed S.R.L. | 2017-04-19 | 405 | 0 |
| DEN130019 | ZANZA-CLICK | Tecnimed S.R.L. | 2014-11-07 | 617 | 0 |
| K122412 | VISIOFOCUS | Tecnimed S.R.L. | 2013-03-13 | 217 | 0 |
| K072108 | MODIFICATION TO THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIE | Tecnimed S.R.L. | 2007-08-31 | 30 | 0 |
| K033790 | THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES | Tecnimed S.R.L. | 2004-06-03 | 182 | 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