510(k) Report

FDA applicant

Cotton High Tech S.L.

Balsareny, ES7 decisions2009–20250 recalls

FDA records 7 decisions for Cotton High Tech S.L. (Balsareny, ES) from 2009 to 2025: 7 510(k) clearances. All are in product code HEB (Tampon, Menstrual, Unscented). Since 2016 its 510(k)s took a median of 60 days from receipt to decision, against 81 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 5 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Cotton High Tech S.L.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2009: 12015: 12019: 12021: 22022: 12025: 1
2009high 2 (2021) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Cotton High Tech S.L. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cotton High Tech S.L.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • HEBTampon, Menstrual, Unscented7decisions

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 60 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 81 days; 3 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 9 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K091084Maxim Menstrual Tampons & Organyc Menstrual TamponsCotton High Tech S.L. · 20093cite it
  • K211775Cohitech Organic Cotton Non-Applicator Cottonlock TamponsCotton High Tech S.L. · 20212cite it
  • K152284Cohitech Non Applicator Organic Cotton Tampons;Cohitech Compact Applicator Organic Cotton TamponsCotton High Tech S.L. · 20151cites it
  • K212479Cohitech Reusable Tampon ApplicatorCotton High Tech S.L. · 20211cites it

What has FDA decided for it lately?

  • K252939Cohitech Organic Cotton Compact Applicator TamponsCotton High Tech S.L. · 2025
  • K220238Cohitech Cottonlock Tampons with Reusable ApplicatorCotton High Tech S.L. · 2022
  • K211775Cohitech Organic Cotton Non-Applicator Cottonlock TamponsCotton High Tech S.L. · 2021
  • K212479Cohitech Reusable Tampon ApplicatorCotton High Tech S.L. · 2021
  • K182813Cohitech Organic Cotton Applicator Tampons LightCotton High Tech S.L. · 2019
  • K152284Cohitech Non Applicator Organic Cotton Tampons;Cohitech Compact Applicator Organic Cotton TamponsCotton High Tech S.L. · 2015
  • K091084Maxim Menstrual Tampons & Organyc Menstrual TamponsCotton High Tech S.L. · 2009

All 7 as Cotton High Tech S.L. →