# K151170: Tosama 100% Organic Cotton Menstrual Tampon

- Pathway: 510(k) (Traditional)
- Applicant: Tosama, D.O.O.
- Decided: Jul 2, 2015 after 62 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.
9 later devices descend from it; 4 cite it directly.
0 of 16 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.

## Most influential descendants
- 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
- K252005: Livi Device (2026), 0 descendants of its own
- K242105: SABA Tampons (2025), 0 descendants of its own

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

Source page: https://510kreport.com/device/K151170
Methodology: https://510kreport.com/methodology