# K231138: Aniti-Snore Mouthguard+

- Pathway: 510(k) (Traditional)
- Applicant: Oscimed SA
- Decided: Jan 16, 2024 after 270 days
- Product code: LRK (Device, Anti-Snoring)
- Device class: 2
- Regulation: 21 CFR 872.5570
- 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 K071404 (2007). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200657: SmartGuard Anti-Snoring Device, Smartguard Rx, Inc. (2021) Summary page 5.

## Indications for use
The device is intended to aid in the reduction of snoring for adults at least 18 years old.

Source page: https://510kreport.com/device/K231138
Methodology: https://510kreport.com/methodology