# K222046: Unscented Menstrual Tampon

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou Borage Medical Technology Co., Ltd.
- Decided: Sep 30, 2022 after 81 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K15117: Tosama 100% Organic Cotton Menstrual Tampon. Number could not be read Summary page 4.

## Most influential descendants
- K240708: Organic Cotton Tampon; Organic Cotton PESCVcord Tampon (2024), 0 descendants of its own

## Indications for use
The unscented menstrual tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.

Source page: https://510kreport.com/device/K222046
Methodology: https://510kreport.com/methodology