# K082849: Silent Sleep

- Pathway: 510(k) (Abbreviated)
- Applicant: Craniofacial Pain Center of Idaho
- Decided: Jul 16, 2009 after 290 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
For the temporary or trial treatment of snoring and mild to moderate obstructive sleep apnea in adults over age 18. The Silent Sleep is not intended to be used for more than 30 days.

Source page: https://510kreport.com/device/K082849
Methodology: https://510kreport.com/methodology