# K172504: Tosama Biobased Applicator Tube Menstrual Tampon

- Pathway: 510(k) (Traditional)
- Applicant: Tosama, D.O.O.
- Decided: Feb 9, 2018 after 175 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: 5 generations back to K040999 (2004). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151170: Tosama 100% Organic Cotton Menstrual Tampon, Tosama, D.O.O. (2015) Summary page 4.

## Indications for use
The Tosama Biobased Applicator Tube Menstrual Tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.

Source page: https://510kreport.com/device/K172504
Methodology: https://510kreport.com/methodology