# K101155: Auradorm (Neuromuscular Sleep)

- Pathway: 510(k) (Traditional)
- Applicant: Sleepwright
- Decided: May 12, 2011 after 381 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: 3 generations back to K011560 (2001). 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)
- K062333: Laimad, Steven Lamberg, D.D.S (2006) Summary page 1.
- K103004: Snore Guard, Ranir, LLC (2011). Cleared while this submission was under review Summary page 1.
- K083209: Acrylic Herbst Splint Appliance, Specialty Appliance Works, Inc. (2009) Summary page 1.

## Indications for use
The Auradorm sleep appliance is a dentist prescribed mandibular repositioning device worn during sleep to reduce the incidence of snoring and reduce the effects of mild to moderate obstructive sleep apnea for patients 18 years or older.

Source page: https://510kreport.com/device/K101155
Methodology: https://510kreport.com/methodology