Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cotton High Tech S.L. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
60 daysmedian FDA review time
163 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252939 | COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS | Cotton High Tech S.L. | 2025-10-09 | 24 | 0 |
| K220238 | Cohitech Cottonlock Tampons with Reusable Applicator | Cotton High Tech S.L. | 2022-02-25 | 28 | 0 |
| K211775 | Cohitech Organic Cotton Non-Applicator Cottonlock Tampons | Cotton High Tech S.L. | 2021-10-22 | 135 | 0 |
| K212479 | Cohitech Reusable Tampon Applicator | Cotton High Tech S.L. | 2021-10-08 | 60 | 0 |
| K182813 | COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT | Cotton High Tech S.L. | 2019-03-15 | 163 | 0 |
| K152284 | COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS;COHITECH COMP | Cotton High Tech S.L. | 2015-12-04 | 114 | 0 |
| K091084 | MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONS | Cotton High Tech S.L. | 2009-04-29 | 14 | 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