510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN210015Unknown

Sunrise Sleep Disorder Diagnostic Aid

Sunrise SA, Namur, BE / Direct, Unknown
FDA source (opens on fda.gov)

DEN210015 is the FDA 510(k) clearance record for Sunrise Sleep Disorder Diagnostic Aid, a class II device, cleared for Sunrise on under FDA product code QRS (Device For Sleep Apnea Testing Based On Mandibular Movement). FDA's definition for product code QRS reads: "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...". FDA records list 3 510(k) clearances for Sunrise, from to . As of , FDA records show no recalls naming DEN210015.

Clearance record

Decision date
Received
(280 days to decision)
Product code
QRS Device For Sleep Apnea Testing Based On Mandibular Movement
Regulation
21 CFR 868.2376
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Sunrise Chaussée De Marche 569/13, Namur, BE
Third party review
No

Clearances, product code QRS

Trailing 12 months

FDA records hold no clearances under product code QRS in the trailing twelve months.

FDA records show no clearances under product code QRS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QRS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260