# K020893: Norad Nocturnal Oral Airway Dilator Appliance

- Pathway: 510(k) (Traditional)
- Applicant: Dennis R. Bailey, Dds
- Decided: May 28, 2002 after 70 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.
7 later devices descend from it; 1 cites it directly.
0 of 8 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) TAP: named in the summary without a submission number
- (no number) EMA: named in the summary without a submission number

## Most influential descendants
- K111680: DR. Greensburg's Hybrid (2011), 6 descendants of its own
- K182312: Zyppah Anti-Snoring Device (2019), 3 descendants of its own
- K252531: Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) (2026), 1 descendant of its own
- K261912: SnØreNegatØr (2026), 0 descendants of its own
- K203462: Advanced Dental Appliance (2021), 0 descendants of its own

## Indications for use
The NOrAD device (appliance) is indicated for use in patients who are Snorers or have mild to moderate obstructive sleep apnea that has been medically diagnosed or are intolerant to nasal CPAP and wish to reduce and manage their condition while sleeping. The device may be used in individuals who have had an overnight sleep study and do not have apnea or have mild to moderate obstructive sleep apnea and their physician has recommended the appliance. The device may also be indicated for a patient that snores and may have obstructive sleep apnea but their physician does not feel a sleep study is indicated and has recommended or referred the patient for appliance therapy. In many instances the decision will have been made after consultation has occurred between the dentist and the physician.

Source page: https://510kreport.com/device/K020893
Methodology: https://510kreport.com/methodology