# K993381: Tongue Stabilizer Device

- Pathway: 510(k) (Traditional)
- Applicant: University of Otago
- Decided: Dec 21, 1999 after 75 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K081965: Mpowrx Snoring Solution (2008), 2 descendants of its own
- K172991: Advanced Dental Applicance (2018), 1 descendant of its own
- K203462: Advanced Dental Appliance (2021), 0 descendants of its own

## Indications for use
To be used for the treatment of simple snoring in both dentate and edentulous patients. Can be used also for the treatment of snoring in patients with periodontically compromised dentitions and likewise patients presenting with Temporo-mandibular Dysfunction (TMD). Cephalometric and video-endoscopy studies have established that tongue protrusion creates a greater increase in oropharyngeal, velopharyngeal and hypopharyngeal cross-sectional areas of the upper airway, hence improving airway patency and function.

Source page: https://510kreport.com/device/K993381
Methodology: https://510kreport.com/methodology