# K150897: Tosama 100% Cotton Menstrual Tampon

- Pathway: 510(k) (Traditional)
- Applicant: Tosama, D.O.O.
- Decided: Apr 20, 2015 after 18 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: 4 generations back to K040999 (2004). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130609: Veeda 100% Cotton Menstrual Tampon, Naturalena Brands, Inc. (2013) Summary page 4.
- K080733: Cottons 100% Natural Cotton Tampons, Cottons Pty, Ltd. (2009) Summary page 4.

## Indications for use
The Tosama 100% Cotton Tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.

Source page: https://510kreport.com/device/K150897
Methodology: https://510kreport.com/methodology