FDA product code QNO: Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea
QNO is the FDA product code for neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea. It is a Class II device, regulated under 21 CFR 872.5575 and reviewed by the Dental panel. FDA has cleared 2 510(k) submissions under QNO, 2 in the last five years. The average 510(k) review took 82 days (median 82); 101 days on average over the last three years. 1 De Novo request was granted under it.
Definition
A neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea consists of a removable intraoral mouthpiece that uses electrodes to deliver neuromuscular stimulation to the tongue to strengthen tongue musculature to reduce snoring and obstructive sleep apnea.
Classification
| Field | Value |
|---|---|
| Device name | Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea |
| Device class | Class II |
| Regulation | 21 CFR 872.5575 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
510(k) clearances per year for QNO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 64 |
| 2024 | 1 | 101 |
Compare with all 510(k) review times · Search every QNO clearance
Top QNO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Signifier Medical Technologies, Ltd. | 2 | 2024-05-16 |
Most recent QNO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K240328 | Signifier Medical Technologies, Ltd. | eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) | 2024-05-16 | 101 |
| K223446 | Signifier Medical Technologies, Ltd. | eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) | 2023-01-18 | 64 |
Recalls for QNO devices
openFDA lists no recalls for product code QNO.
Frequently asked questions
What is FDA product code QNO?
QNO is the FDA product code for neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea. It is a Class II device, regulated under 21 CFR 872.5575 and reviewed by the Dental panel.
What device class is QNO?
Class II, regulation 21 CFR 872.5575. Typical premarket route: 510(k).
How long does a 510(k) take for product code QNO?
Across 2 cleared submissions the average was 82 days from receipt to decision (median 82).
Which companies have the most QNO clearances?
Signifier Medical Technologies, Ltd. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code QNO
- Run a recall and safety report across every QNO manufacturer
- Watch product code QNO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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