FDA product code QRS: Device For Sleep Apnea Testing Based On Mandibular Movement
QRS is the FDA product code for device for sleep apnea testing based on mandibular movement. It is a Class II device, regulated under 21 CFR 868.2376 and reviewed by the Anesthesiology panel. FDA has cleared 2 510(k) submissions under QRS, 2 in the last five years. The average 510(k) review took 152 days (median 152); 158 days on average over the last three years. 1 De Novo request was granted under it.
Definition
A device for sleep apnea testing based on mandibular movement is a prescription device intended to aid in evaluation of sleep apnea during sleep in patients suspected of having sleep breathing disorders by analyzing sensor readings of mandibular movement. The device is not intended as a substitute for full polysomnography nor intended to be used as an apnea monitor.
Classification
| Field | Value |
|---|---|
| Device name | Device For Sleep Apnea Testing Based On Mandibular Movement |
| Device class | Class II |
| Regulation | 21 CFR 868.2376 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
510(k) clearances per year for QRS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 147 |
| 2025 | 1 | 158 |
Compare with all 510(k) review times · Search every QRS clearance
Top QRS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sunrise SA | 2 | 2025-08-29 |
Most recent QRS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250874 | Sunrise SA | Sunrise | 2025-08-29 | 158 |
| K222262 | Sunrise SA | Sunrise | 2022-12-22 | 147 |
Recalls for QRS devices
openFDA lists no recalls for product code QRS.
Frequently asked questions
What is FDA product code QRS?
QRS is the FDA product code for device for sleep apnea testing based on mandibular movement. It is a Class II device, regulated under 21 CFR 868.2376 and reviewed by the Anesthesiology panel.
What device class is QRS?
Class II, regulation 21 CFR 868.2376. Typical premarket route: 510(k).
How long does a 510(k) take for product code QRS?
Across 2 cleared submissions the average was 152 days from receipt to decision (median 152).
Which companies have the most QRS clearances?
Sunrise SA (2).
Next steps
- Run an FDA pathway report with predicate devices for product code QRS
- Run a recall and safety report across every QRS manufacturer
- Watch product code QRS 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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