Tosama, D.O.O.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Tosama, D.O.O.” (first 2012, latest 2024), across 1 product code in 1 review panel. Median 510(k) review time under this name: 148 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 148 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 2 | 40 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 175 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 276 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Tosama, D.O.O. took a median 226 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 132 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HEB | Tampon, Menstrual, Unscented | 5 | 5 |
Review panels
Most recent Tosama, D.O.O. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232060 | TOSAMA Reusable Applicator | HEB | 2024-04-12 | 276 |
| K172504 | Tosama Biobased Applicator Tube Menstrual Tampon | HEB | 2018-02-09 | 175 |
| K151170 | Tosama 100% Organic Cotton Menstrual Tampon | HEB | 2015-07-02 | 62 |
| K150897 | Tosama 100% Cotton Menstrual Tampon | HEB | 2015-04-20 | 18 |
| K120481 | LIL-LETS SILK COMFORT COMPACT, PLASTIC APPLICATOR, LITE, REGULAR, SUPER, SUPER PLUS AND ULTRA LIL-LETS NON APPLICATOR, | HEB | 2012-07-13 | 148 |
Recalls
openFDA lists no recalls under a recalling firm named Tosama, D.O.O..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Tosama D.D. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Tosama, D.O.O.?
FDA lists 5 510(k) clearances under the applicant name “Tosama, D.O.O.” (first 2012, latest 2024), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Tosama, D.O.O.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tosama, D.O.O. is 148 days.
Which FDA product codes appear under Tosama, D.O.O.?
The most frequent FDA product codes under this applicant name are HEB (Tampon, Menstrual, Unscented, 5).
Next steps
- See all 5 Tosama, D.O.O. clearances with predicates and recalls
- Run predicate analysis for product code HEB, Tosama, D.O.O.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.