# K182813: Cohitech Organic Cotton Applicator Tampons Light

- Pathway: 510(k) (Special)
- Applicant: Cotton High Tech S.L.
- Decided: Mar 15, 2019 after 163 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: 3 generations back to K040999 (2004). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091084: Maxim Menstrual Tampons & Organyc Menstrual Tampons, Cotton High Tech S.L. (2009) Summary page 4.

## Indications for use
COHITECH Organic cotton cardboard applicator tampons light are unscented menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.

Source page: https://510kreport.com/device/K182813
Methodology: https://510kreport.com/methodology