# K191618: SleepTight Mouthpiece STZ

- Pathway: 510(k) (Traditional)
- Applicant: Michael D Williams Dds PA
- Decided: Dec 11, 2019 after 176 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: 7 generations back to K882303 (1989). 23 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170825: SnoreRx, Apnea Sciences Corporation (2017) Summary page 4.
- K132506: Sleeptight Mouthpiece, Sleeppro, Quietnite, Altitude Mouthpiece, Sleep Easy, Michael D Williams Dds PA (2014) Summary page 4.
- K180124: ZQuiet, Sleeping Well, LLC (2018) Summary page 4.

## Most influential descendants
- K252531: Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) (2026), 1 descendant of its own
- K261912: SnØreNegatØr (2026), 0 descendants of its own
- K210910: Snore Bandit (2021), 0 descendants of its own

## Indications for use
The SleepTight Mouthpiece (STZ) is intended for use by adult patients 18 years of age or older as an aid to reduce snoring.

Source page: https://510kreport.com/device/K191618
Methodology: https://510kreport.com/methodology