# K190687: Twilite Appliance

- Pathway: 510(k) (Traditional)
- Applicant: Stephen J Harkins, Dds, PC
- Decided: Jul 2, 2019 after 106 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: 11 generations back to K882303 (1989). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172859: Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder, Prosomnous Sleep Technologies (2017) Summary page 4.

## Indications for use
The Twilite Appliance ® is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18 years and older.

Source page: https://510kreport.com/device/K190687
Methodology: https://510kreport.com/methodology