# Cotton High Tech S.L.

- Location (FDA's records): Balsareny, ES
- FDA decisions: 7 (2009–2025): 7 510(k) clearances
- Product codes: HEB (7)
- 510(k) review time since 2016: median 60 days, against 81 for FDA's reviews in the same codes and years (3 of 5 faster)
- Predicates its devices cite: 9 (5 its own); citations of its devices by later devices: 7 (5 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Procter & Gamble Co.: 1 (https://510kreport.com/company/procter-gamble)
- Bodywise (Uk), Ltd.: 1 (https://510kreport.com/company/bodywise-uk)
- Personal Products Co.: 1 (https://510kreport.com/company/personal-products)
- Thinx, Inc.: 1 (https://510kreport.com/company/thinx)

## Firms that cite its devices most
- Naturalena Brands, Inc.: 1 (https://510kreport.com/company/naturalena-brands)
- Tosama, D.O.O.: 1 (https://510kreport.com/company/tosama-doo)

## Its most-cited devices
- K091084: Maxim Menstrual Tampons & Organyc Menstrual Tampons (2009), cited by 3
- K211775: Cohitech Organic Cotton Non-Applicator Cottonlock Tampons (2021), cited by 2
- K152284: Cohitech Non Applicator Organic Cotton Tampons;Cohitech Compact Applicator Organic Cotton Tampons (2015), cited by 1
- K212479: Cohitech Reusable Tampon Applicator (2021), cited by 1

## Recent decisions
- K252939: Cohitech Organic Cotton Compact Applicator Tampons (Oct 9, 2025)
- K220238: Cohitech Cottonlock Tampons with Reusable Applicator (Feb 25, 2022)
- K211775: Cohitech Organic Cotton Non-Applicator Cottonlock Tampons (Oct 22, 2021)
- K212479: Cohitech Reusable Tampon Applicator (Oct 8, 2021)
- K182813: Cohitech Organic Cotton Applicator Tampons Light (Mar 15, 2019)
- K152284: Cohitech Non Applicator Organic Cotton Tampons;Cohitech Compact Applicator Organic Cotton Tampons (Dec 4, 2015)
- K091084: Maxim Menstrual Tampons & Organyc Menstrual Tampons (Apr 29, 2009)

Source page: https://510kreport.com/company/cotton-high-tech