FDA Product Code QRS: Device For Sleep Apnea Testing Based On Mandibular Movement
A Device For Sleep Apnea Testing Based On Mandibular Movement Is A Prescription Device Intended To Aid In Evaluation Of Sleep Apnea During Sleep In Patients Suspected Of Having Sleep Breathing Disorders By Analyzing Sensor Readings Of Mandibular Movement. The Device Is Not Intended As A Substitute For Full Polysomnography Nor Intended To Be Used As An Apnea Monitor.
Leading manufacturers include Sunrise SA and Sunrise.
FDA 510(k) Cleared Device For Sleep Apnea Testing Based On Mandibular Movement Devices (Product Code QRS)
About Product Code QRS - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code QRS since 2022, with 2 receiving FDA clearance (average review time: 195 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 QRS have taken an average of 158 days to reach a decision - down from 214 days historically, suggesting improved FDA processing for this classification.
QRS devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →