# K201484: Somnos Anti-Snoring Mouth Guard

- Pathway: 510(k) (Traditional)
- Applicant: Koncept Innovators, LLC
- Decided: Nov 23, 2020 after 172 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: 6 generations back to K071404 (2007). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170825: SnoreRx, Apnea Sciences Corporation (2017) Summary page 4.

## Most influential descendants
- K261134: Dormiva Anti-Snoring Mouth Guard (2026), 0 descendants of its own

## Indications for use
SOMNOS ANTI-SNORING MOUTH GUARD is an over-the-counter mouthguard intended for use in adult persons 18 years of age or older as an aid for the reduction of snoring.

Source page: https://510kreport.com/device/K201484
Methodology: https://510kreport.com/methodology