Cotton High Tech S.L.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Cotton High Tech S.L.” (first 2009, latest 2025), across 1 product code in 1 review panel. Median 510(k) review time under this name: 60 days. Since 2017 the median was 60 days, against 132 days for all cleared 510(k)s in the same product codes. 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 114 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 163 |
| 2020 | 0 | — |
| 2021 | 2 | 98 |
| 2022 | 1 | 28 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 24 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Cotton High Tech S.L. took a median 60 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 | 7 | 7 |
Review panels
Most recent Cotton High Tech S.L. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252939 | COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS | HEB | 2025-10-09 | 24 |
| K220238 | Cohitech Cottonlock Tampons with Reusable Applicator | HEB | 2022-02-25 | 28 |
| K211775 | Cohitech Organic Cotton Non-Applicator Cottonlock Tampons | HEB | 2021-10-22 | 135 |
| K212479 | Cohitech Reusable Tampon Applicator | HEB | 2021-10-08 | 60 |
| K182813 | COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT | HEB | 2019-03-15 | 163 |
| K152284 | COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS;COHITECH COMPACT APPLICATOR ORGANIC COTTON TAMPONS | HEB | 2015-12-04 | 114 |
| K091084 | MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONS | HEB | 2009-04-29 | 14 |
Recalls
openFDA lists no recalls under a recalling firm named Cotton High Tech S.L..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Cotton High Tech S.L.?
FDA lists 7 510(k) clearances under the applicant name “Cotton High Tech S.L.” (first 2009, latest 2025), 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 Cotton High Tech S.L.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cotton High Tech S.L. is 60 days. Since 2017: 60 days, versus 132 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Cotton High Tech S.L.?
The most frequent FDA product codes under this applicant name are HEB (Tampon, Menstrual, Unscented, 7).
Next steps
- See all 7 Cotton High Tech S.L. clearances with predicates and recalls
- Run predicate analysis for product code HEB, Cotton High Tech S.L.'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.