# K211775: Cohitech Organic Cotton Non-Applicator Cottonlock Tampons

- Pathway: 510(k) (Traditional)
- Applicant: Cotton High Tech S.L.
- Decided: Oct 22, 2021 after 135 days
- Product code: HEB (Tampon, Menstrual, Unscented)
- Device class: 2
- Regulation: 21 CFR 884.5470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K040999 (2004). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152284: Cohitech Non Applicator Organic Cotton Tampons;Cohitech Compact Applicator Organic Cotton Tampons, Cotton High Tech S.L. (2015) Summary page 4.

## Most influential descendants
- K252939: Cohitech Organic Cotton Compact Applicator Tampons (2025), 0 descendants of its own
- K220238: Cohitech Cottonlock Tampons with Reusable Applicator (2022), 0 descendants of its own

## Indications for use
COHITECH Organic Cotton Non-Applicator Cottonlock Tampons (light, regular, super, and super plus absorbencies) are inserted into the vagina and used to absorb menstrual fluid.

Source page: https://510kreport.com/device/K211775
Methodology: https://510kreport.com/methodology