# K093340: Pasr/Quietnite

- Pathway: 510(k) (Abbreviated)
- Applicant: Exact Supplies, Ltd.
- Decided: Jun 11, 2010 after 228 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. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K97242: SilentNite 4. Number could not be read Summary page 2.

## Indications for use
The PAsr/QuietNite, a dentist prescribed mandibular repositioning/advancement device is intended for the treatment of nighttime incidents of snoring and/or mild to moderate obstructive sleep apnea in persons 18 years of age or older. These devices are not indicated for the treatment of central apnea or severe obstructive sleep apnea and should only be prescribed by a Dentist after the undertaking of a sleep study.

Source page: https://510kreport.com/device/K093340
Methodology: https://510kreport.com/methodology