# K150941: Somnowell Mandibular Advancement Appliance (MAA)

- Pathway: 510(k) (Traditional)
- Applicant: Somnowell, Ltd.
- Decided: May 22, 2015 after 44 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: 5 generations back to K882303 (1989). 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)
- K113516: Therasom-Cast, Family Dental Services, P.C. (2013) Summary page 5.

## Indications for use
The Somnowell Mandibular Advancement Appliance (Somnowell MAA) is intended for the treatment of night time snoring and mild to moderate obstructive sleep apnea (OSA) in patients 18 years of age or older.

Source page: https://510kreport.com/device/K150941
Methodology: https://510kreport.com/methodology