# K253662: Lixi (LXOSFM1)

- Pathway: 510(k) (Traditional)
- Applicant: Luwi, LLC
- Decided: Jul 14, 2026 after 236 days
- Product code: MSC (Barrier, Std, Oral Sex)
- Device class: 2
- Regulation: 21 CFR 884.5300
- 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 K990067 (1999). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212928: Lorals, Brazen Goods Inc. Dba Lorals (2022) Summary page 5.

## Indications for use
LIXI (Ixosfm1) are used as a barrier when engaging in oral/vaginal and oral/anal sex to help reduce the transmission of bodily fluids, harmful pathogens, and sexually transmitted infections.

Source page: https://510kreport.com/device/K253662
Methodology: https://510kreport.com/methodology