# K261912: SnØreNegatØr

- Pathway: 510(k) (Traditional)
- Applicant: DnB Innovations, LLC
- Decided: Jul 31, 2026 after 53 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: 10 generations back to K882303 (1989). 44 ancestors in all.
No later device cites it as a predicate yet.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K252531: Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2), Myofunctional Research Co. (2026) Summary page 5.

## Indications for use
OTC: The Sn@reNegat@r is intended to treat snoring in adults at least 18 years old. Rx: The Sn@reNegat@r is intended to treat snoring and mild to moderate obstructive sleep apnea in adults at least 18 years old.

Source page: https://510kreport.com/device/K261912
Methodology: https://510kreport.com/methodology