# K252005: Livi Device

- Pathway: 510(k) (Traditional)
- Applicant: Liviwell, Inc.
- Decided: Mar 20, 2026 after 266 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: 7 generations back to K040999 (2004). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241064: Unscented Tampon, Shandong Intco Hygiene Products Co., Ltd. (2025) Summary page 5.

## Indications for use
The Livi device is intended for insertion into the vagina following sexual intercourse for the absorption of semen or other vaginal discharge. The device does not prevent pregnancy or protect against sexually transmitted infections (STIs).

Source page: https://510kreport.com/device/K252005
Methodology: https://510kreport.com/methodology