# K091084: Maxim Menstrual Tampons & Organyc Menstrual Tampons

- Pathway: 510(k) (Traditional)
- Applicant: Cotton High Tech S.L.
- Decided: Apr 29, 2009 after 14 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: 2 generations back to K040999 (2004). 3 ancestors in all.
17 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061486: Tampax Tampons - (Light,Regular,Super and Super Plus Absorbencies), Procter & Gamble Co. (2006) Summary page 2.
- K954942: Natracaren Applicator Tampon, Bodywise (Uk), Ltd. (1996) Summary page 1.

## Most influential descendants
- K130609: Veeda 100% Cotton Menstrual Tampon (2013), 11 descendants of its own
- K151170: Tosama 100% Organic Cotton Menstrual Tampon (2015), 9 descendants of its own
- K231341: Organic cotton tampon, Viscose tampon (2023), 3 descendants of its own
- K152284: Cohitech Non Applicator Organic Cotton Tampons;Cohitech Compact Applicator Organic Cotton Tampons (2015), 3 descendants of its own
- K211775: Cohitech Organic Cotton Non-Applicator Cottonlock Tampons (2021), 2 descendants of its own

## Indications for use
Cotton menstrual tampons are unscented menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.

Source page: https://510kreport.com/device/K091084
Methodology: https://510kreport.com/methodology