# K261134: Dormiva Anti-Snoring Mouth Guard

- Pathway: 510(k) (Special)
- Applicant: Koncept Innovators, Inc.
- Decided: May 14, 2026 after 37 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)
- K201484: Somnos Anti-Snoring Mouth Guard, Koncept Innovators, LLC (2020) Summary page 5.

## Indications for use
DORMIVA ANTI-SNORING MOUTH GUARD is an over-the-counter mouth guard 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/K261134
Methodology: https://510kreport.com/methodology