DeviceClearance

Product code QZW— Anesthesiology

Sleep Apnea Feature

Classification name
Over-The-Counter Device To Assess Risk Of Sleep Apnea
Device class
Class 2
Regulation
21 CFR 868.2378
Advisory panel
Anesthesiology
Total cleared
3
First cleared
Most recent

FDA classification definition

“An over-the-counter device to assess risk of sleep apnea is intended to provide a notification of the risk of sleep apnea in users who have not been previously diagnosed with sleep apnea. This device uses software algorithms to analyze input sensor signals and provide a risk assessment for sleep apnea. It is not intended to provide a standalone diagnosis, replace traditional methods of diagnosis (e.g., polysomnography), assist clinicians in diagnosing sleep disorders, or be used as an apnea monitor.”

— U.S. Food and Drug Administration, device classification record for product code QZW under 21 CFR 868.2378, via openFDA

Market context for product code QZW

FDA has cleared 3 devices under product code QZW between 2024 and 2026, 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 QZW

Recent clearances under product code QZW

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