# K140777: Zquiet-SA

- Pathway: 510(k) (Traditional)
- Applicant: Sleeping Well, LLC
- Decided: Jul 25, 2014 after 119 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: 6 generations back to K882303 (1989). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093407: Zquiet Mouthpiece, Sleeping Well, LLC (2010) Summary page 1.
- K090503: Zquiet Mouthpiece, Sleeping Well, LLC (2009) Summary page 4.
- K061688: Anti-Snoring / Sleep Apnea Device, Tomed Dr. Toussaint GmbH (2006) Summary page 1.

## Indications for use
ZQuiet-SA is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in adults.

Source page: https://510kreport.com/device/K140777
Methodology: https://510kreport.com/methodology