# K242105: SABA Tampons

- Pathway: 510(k) (Traditional)
- Applicant: Essity Higiene Y Salud Mexico. S.A. DE C.V.
- Decided: Apr 1, 2025 after 257 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.
No later device cites it as a predicate yet.
0 of 9 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.

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

Source page: https://510kreport.com/device/K242105
Methodology: https://510kreport.com/methodology