DeviceClearance

Product code QBY— Anesthesiology

Curve Positive Airway Pressure System

Classification name
Positive Airway Pressure System
Device class
Class 2
Regulation
21 CFR 868.5273
Advisory panel
Anesthesiology
Total cleared
2
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code QBY under 21 CFR 868.5273, via openFDA

Market context for product code QBY

FDA has cleared 2 devices under product code QBY between 2018 and 2020, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QBY

Recent clearances under product code QBY

Data sourced from openFDA. This site is unofficial and independent of the FDA.