# K190218: Unscented Menstrual Tampon

- Pathway: 510(k) (Traditional)
- Applicant: Qingdao Youjia Hygiene Technology Co., Ltd.
- Decided: May 9, 2019 after 94 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: 3 generations back to K914430 (1993). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090819: Ontex Tampon (Unscented), Ontex International NV (2009) Summary page 4.

## Most influential descendants
- K192557: Youjia Unscented Tampon with Plastic Applicators (2020), 0 descendants of its own

## Indications for use
The BiuBiu tampon is inserted into the vagina and used to absorb menstrual and other vaginal discharge.

Source page: https://510kreport.com/device/K190218
Methodology: https://510kreport.com/methodology