# K212928: Lorals

- Pathway: 510(k) (Traditional)
- Applicant: Brazen Goods Inc. Dba Lorals
- Decided: Apr 22, 2022 after 220 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: 2 generations back to K990067 (1999). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091769: Trust Dam, Line One Laboratories, Inc. (2010) Summary page 4.

## Most influential descendants
- K253662: Lixi (LXOSFM1) (2026), 0 descendants of its own

## Indications for use
Lorals 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/K212928
Methodology: https://510kreport.com/methodology