510(k) · Cleared
ClearedNorad Nocturnal Oral Airway Dilator Appliance
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dennis R. Bailey, Dds · LRK Device, Anti-Snoring
Cleared on May 28, 2002 after a 70-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.
- Decided
- May 28, 2002
- Review
- 70 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK020893 Norad Nocturnal Oral Airway Dilator ApplianceDennis R. Bailey, Dds · 2002
- Descendant · cites it directly · 6 of its ownK111680 DR. Greensburg's HybridAlways More Marketing, Inc. · 2011
- Descendant · 2 generations on · 3 of its ownK182312 Zyppah Anti-Snoring DeviceAlways More Marketing · 2019
- Descendant · 2 generations on · 1 of its ownK252531 Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)Myofunctional Research Co. · 2026
- Descendant · 3 generations on · 0 of its ownK261912 SnØreNegatØrDnB Innovations, LLC · 2026
- Descendant · 3 generations on · 0 of its ownK203462 Advanced Dental ApplianceDasoft Partners · 2021
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K111680DR. Greensburg's HybridAlways More Marketing, Inc. · 2011 · cites it directly6descendants
- K182312Zyppah Anti-Snoring DeviceAlways More Marketing · 2019 · 2 generations on3descendants
- K252531Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)Myofunctional Research Co. · 2026 · 2 generations on1descendant
- K261912SnØreNegatØrDnB Innovations, LLC · 2026 · 3 generations on0descendants
- K203462Advanced Dental ApplianceDasoft Partners · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K020893 | Norad Nocturnal Oral Airway Dilator Appliance | Dennis R. Bailey, Dds | 2002 | — |
| +1 | K111680 | DR. Greensburg's Hybrid | Always More Marketing, Inc. | 2011 | — |
| +2 | K182312 | Zyppah Anti-Snoring Device | Always More Marketing | 2019 | — |
| +2 | K252531 | Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) | Myofunctional Research Co. | 2026 | — |
| +3 | K261912 | SnØreNegatØr | DnB Innovations, LLC | 2026 | — |
| +3 | K203462 | Advanced Dental Appliance | Dasoft Partners | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LRK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LRK device
- #1 K252531 Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for…score 16.3 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Silencer Custom Named without a submission number | |
| * | — | TAP Named without a submission number | |
| * | — | EMA Named without a submission number |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111680 | DR. Greensburg's Hybrid | 2011 | 6 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K111680 (Always More Marketing, Inc., 2011) has gone furthest, with 6 descendants of its own.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LRK
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LRK
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LRK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LRK
653in 2025
MAUDE reports naming product code LRK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 3 | 109 | 0 | 1 |
| 2009 | 3 | 88 | 2 | 11 |
| 2010 | 8 | 195 | 0 | 7 |
| 2011 | 10 | 134 | 0 | 69 |
| 2012 | 10 | 142 | 0 | 445 |
| 2013 | 9 | 233 | 0 | 72 |
| 2014 | 11 | 219 | 0 | 49 |
| 2015 | 6 | 117 | 0 | 28 |
| 2016 | 10 | 157 | 0 | 18 |
| 2017 | 7 | 170 | 0 | 32 |
| 2018 | 10 | 200 | 0 | 61 |
| 2019 | 13 | 150 | 0 | 56 |
| 2020 | 5 | 80 | 0 | 24 |
| 2021 | 10 | 126 | 0 | 49 |
| 2022 | 11 | 154 | 0 | 40 |
| 2023 | 5 | 156 | 0 | 50 |
| 2024 | 6 | 254 | 0 | 185 |
| 2025 | 14 | 107 | 1 | 653 |
| 2026 | 10 | 63 | 1 | — |
What is it indicated for?
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…
Read the full statement (133 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020893 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020893: Norad Nocturnal Oral Airway Dilator Appliance.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020893
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026