# K060122: Sleep Splint

- Pathway: 510(k) (Traditional)
- Applicant: Nakagawa Dental Clinic
- Decided: May 19, 2006 after 122 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: 1 generation back to K882303 (1989). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K882303: H&M Anti-Snoring Device, Hays & Meade, Inc. (1989) Summary page 1.
- K954530: The Silencer, Silent Knights Ventures, Inc. (1995) Summary page 1.

## Indications for use
The Sleep Splint is intended to be prescribed to adult patients to aid in the reduction and management of snoring and mild to moderate obstructive sleep apnea.

Source page: https://510kreport.com/device/K060122
Methodology: https://510kreport.com/methodology