QBYClass II
Positive Airway Pressure System
21 CFR 868.5273 / Anesthesiology
QBY is the FDA product code for Positive Airway Pressure System, a class II device type, regulated under 21 CFR 868.5273. FDA's definition for this code reads: "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...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QBY
- Device name
- Positive Airway Pressure System
- FDA 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.
- Regulation
- 21 CFR 868.5273
- Device class
- Class II
- Review panel
- Anesthesiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 2
- Ingested recalls
- 0
Clearances, product code QBY
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2018 | 1 |
| 2020 | 1 |
Applicants with the most clearances
Product code QBY| Applicant | Clearances |
|---|---|
| Fresca Medical | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.