DeviceClearance

Product code QRS— Ear, Nose, Throat

Sunrise

Classification name
Device For Sleep Apnea Testing Based On Mandibular Movement
Device class
Class 2
Regulation
21 CFR 868.2376
Advisory panel
Ear, Nose, Throat
Total cleared
3
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code QRS under 21 CFR 868.2376, via openFDA

Market context for product code QRS

FDA has cleared 3 devices under product code QRS between 2022 and 2025, 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 QRS

Recent clearances under product code QRS

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