# K080733: Cottons 100% Natural Cotton Tampons

- Pathway: 510(k) (Abbreviated)
- Applicant: Cottons Pty, Ltd.
- Decided: Feb 18, 2009 after 341 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). 2 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 15 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 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
- K182817: CottonDay Tampon (2019), 2 descendants of its own
- K241064: Unscented Tampon (2025), 1 descendant of its own

## Indications for use
Cottons Ltd, 100% Cotton Tampons are unscented, digital and applicator menstrual tampons for the absorption of menstrual fluid.

Source page: https://510kreport.com/device/K080733
Methodology: https://510kreport.com/methodology