FDA Product Code QZW: Over-the-counter Device To Assess Risk Of Sleep Apnea
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.
Leading manufacturers include Samsung Electronics Co., Ltd. and Apple, Inc..
FDA 510(k) Cleared Over-the-counter Device To Assess Risk Of Sleep Apnea Devices (Product Code QZW)
About Product Code QZW - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code QZW since 2024, with 1 receiving FDA clearance (average review time: 207 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under QZW have taken an average of 162 days to reach a decision - down from 251 days historically, suggesting improved FDA processing for this classification.
QZW devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →