Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tosama, D.O.O. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
148 daysmedian FDA review time
276 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232060 | TOSAMA Reusable Applicator | Tosama, D.O.O. | 2024-04-12 | 276 | 0 |
| K172504 | Tosama Biobased Applicator Tube Menstrual Tampon | Tosama, D.O.O. | 2018-02-09 | 175 | 0 |
| K151170 | Tosama 100% Organic Cotton Menstrual Tampon | Tosama, D.O.O. | 2015-07-02 | 62 | 0 |
| K150897 | Tosama 100% Cotton Menstrual Tampon | Tosama, D.O.O. | 2015-04-20 | 18 | 0 |
| K120481 | LIL-LETS SILK COMFORT COMPACT, PLASTIC APPLICATOR, LITE, REG | Tosama, D.O.O. | 2012-07-13 | 148 | 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