# K241064: Unscented Tampon

- Pathway: 510(k) (Traditional)
- Applicant: Shandong Intco Hygiene Products Co., Ltd.
- Decided: Jan 10, 2025 after 267 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: 6 generations back to K040999 (2004). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231341: Organic cotton tampon, Viscose tampon, Zhejiang Tianqing Manufacturing Technology Group Co., Ltd. (2023) Summary page 5.

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

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

Source page: https://510kreport.com/device/K241064
Methodology: https://510kreport.com/methodology