# K252939: Cohitech Organic Cotton Compact Applicator Tampons

- Pathway: 510(k) (Special)
- Applicant: Cotton High Tech S.L.
- Decided: Oct 9, 2025 after 24 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: 5 generations back to K040999 (2004). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211775: Cohitech Organic Cotton Non-Applicator Cottonlock Tampons, Cotton High Tech S.L. (2021) Summary page 5.

## Indications for use
COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS (light, regular, super, and super plus) are inserted into the vagina and used to absorb menstrual fluids.

Source page: https://510kreport.com/device/K252939
Methodology: https://510kreport.com/methodology