# K013049: Norad, Nocturnal Oral Airway Dilator Appliance

- Pathway: 510(k) (Traditional)
- Applicant: Dennis R. Bailey, Dds
- Decided: Nov 29, 2001 after 79 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Silencer Custom: named in the summary without a submission number
- (no number) Therasnore: named in the summary without a submission number

## Most influential descendants
- K060795: Somnofit (2006), 0 descendants of its own

## Indications for use
The NOrAD device is indicated for use in patients who are snorers and wish to reduce or otherwise manage their snoring while sleeping. The device is to be used with individuals in whom it has been determined that they are primary snorers and are not at risk for sleep apnea. In many instances these individuals may have had a sleep study and have been found to have a Respiratory Disturbance Index (RDI) below the level that necessitates a diagnosis for sleep apnea. They may also be individuals who are snorers and whose physician has determined that they are not candidates for a sleep study and may proceed with management of their snoring utilizing this device. Many times this decision will have been achieved after consultation has occurred between the dentist and their physician.

Source page: https://510kreport.com/device/K013049
Methodology: https://510kreport.com/methodology