# K123410: Healthy Sleep Appliance

- Pathway: 510(k) (Traditional)
- Applicant: Healthy Sleep Dental Laboratory
- Decided: Apr 5, 2013 after 151 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: 2 generations back to K070327 (2007). 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)
- K083209: Acrylic Herbst Splint Appliance, Specialty Appliance Works, Inc. (2009) Summary page 1.

## Indications for use
The Healthy Sleep Appliance is intended for use in patients 18 years of age or older for the reduction of snoring and mild to moderate obstructive sleep apnea.

Source page: https://510kreport.com/device/K123410
Methodology: https://510kreport.com/methodology