# K251628: Mandibular Advancement Device L07

- Pathway: 510(k) (Traditional)
- Applicant: Dcstar, Inc.
- Decided: Oct 22, 2025 after 147 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 K071404 (2007). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 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 5.

## Indications for use
The Mandibular Advancement Device is designed to advance the user's lower jaw and maintain this position during use, opening the airway to reduce snoring during sleep. It is intended for adults with at least 18 years old.

Source page: https://510kreport.com/device/K251628
Methodology: https://510kreport.com/methodology