# K152284: Cohitech Non Applicator Organic Cotton Tampons;Cohitech Compact Applicator Organic Cotton Tampons

- Pathway: 510(k) (Traditional)
- Applicant: Cotton High Tech S.L.
- Decided: Dec 4, 2015 after 114 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). 5 ancestors in all.
3 later devices descend from it; 1 cites 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)
- K991118: O.B. Applicator Tampons, O.B. Tampons, Personal Products Co. (1999) Summary page 4.
- K091084: Maxim Menstrual Tampons & Organyc Menstrual Tampons, Cotton High Tech S.L. (2009) Summary page 4.

## Most influential descendants
- K211775: Cohitech Organic Cotton Non-Applicator Cottonlock Tampons (2021), 2 descendants of its own
- 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 Non Applicator Organic Cotton Tampons and Cohitech Compact Applicator Organic Cotton Tampons (regular, super and super plus absorbencies) are inserted into the vagina and used to absorb menstrual fluid.

Source page: https://510kreport.com/device/K152284
Methodology: https://510kreport.com/methodology