# K012142: The Quiet Sleeper

- Pathway: 510(k) (Traditional)
- Applicant: Precision Dental Laboratories, Inc.
- Decided: Oct 4, 2001 after 86 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
The “Quiet Sleeper” is intended to reduce the severity of snoring, and mild to moderate obstructive sleep apnea. Several studies have shown the effectiveness of oral appliances that position the mandible forward for the treatment of simple snoring and mild to moderate sleep apnea.

Source page: https://510kreport.com/device/K012142
Methodology: https://510kreport.com/methodology