Is Sunrise FDA cleared?

FDA's records list K250874 for Sunrise from Sunrise SA: 510(k), decision date Aug 29, 2025, decision "Substantially Equivalent". The 510(k) pathway means the device was cleared, not approved.

What product code is K250874?

QRS: Device For Sleep Apnea Testing Based On Mandibular Movement, regulated under 21 CFR 868.2376, class 2.

FDA 510(k) · Sunrise

K250874: Sunrise (Sunrise SA)

Sunrise SA received FDA 510(k) K250874 for Sunrise, with a decision date of Aug 29, 2025 (substantially equivalent).

Prescription or OTC: Unknown (no FDA document we parsed states it).

FDA record for K250874 FDA summary or statement (PDF)

FDA facts

Official fields for K250874
FDA number	K250874
Pathway	510(k)
Applicant	Sunrise SA
Device name	Sunrise
Product code	QRS: Device For Sleep Apnea Testing Based On Mandibular Movement
Regulation (21 CFR)	868.2376
Device class	Class 2
Date received	Mar 24, 2025
Decision date	Aug 29, 2025
Decision	Substantially Equivalent (SESE)
510(k) type	Traditional

Source: openFDA device 510(k) data, data through Oct 26, 2026.

Indications for use parsed from FDA documents

(Describe) Sunrise Air Device Name K250874 510(k) Number (ifknown) Indications for Use See PRA Statement below. Food and Drug Administration Expiration Date: 07/31/2026 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 510(K) SUMMARY

Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.

Predicates parsed from FDA documents

FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.

K222262 Sunrise (Sunrise)
K201054
DEN210015 Sunrise Sleep Disorder Diagnostic Aid (Sunrise)

ChatPPG interpretation

A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.

Product code QRS is "Device For Sleep Apnea Testing Based On Mandibular Movement", class 2, 21 CFR 868.2376. FDA's 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."

Our labels for filtering: claim Sleep apnea, sensor Other. These are heuristics, not FDA fields.