FDA product code QBY: Positive Airway Pressure System
QBY is the FDA product code for positive airway pressure system. It is a Class II device, regulated under 21 CFR 868.5273 and reviewed by the Anesthesiology panel. FDA has cleared 1 510(k) submission under QBY. The average 510(k) review took 104 days (median 104). 1 De Novo request was granted under it.
Definition
A positive airway pressure delivery system is a prescription noninvasive ventilatory device that delivers expiratory positive airway pressure for patients suffering from obstructive sleep apnea. The system also provides positive airway pressure during incipient apnea. The system may include a dedicated flow generator and a patient interface.
Classification
| Field | Value |
|---|---|
| Device name | Positive Airway Pressure System |
| Device class | Class II |
| Regulation | 21 CFR 868.5273 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
510(k) clearances per year for QBY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 104 |
Compare with all 510(k) review times · Search every QBY clearance
Top QBY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fresca Medical, Inc. | 1 | 2020-06-29 |
Most recent QBY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K200698 | Fresca Medical, Inc. | Somnera System | 2020-06-29 | 104 |
Recalls for QBY devices
openFDA lists no recalls for product code QBY.
Frequently asked questions
What is FDA product code QBY?
QBY is the FDA product code for positive airway pressure system. It is a Class II device, regulated under 21 CFR 868.5273 and reviewed by the Anesthesiology panel.
What device class is QBY?
Class II, regulation 21 CFR 868.5273. Typical premarket route: 510(k).
How long does a 510(k) take for product code QBY?
Across 1 cleared submissions the average was 104 days from receipt to decision (median 104).
Which companies have the most QBY clearances?
Fresca Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QBY
- Run a recall and safety report across every QBY manufacturer
- Watch product code QBY 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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