Cleared Traditional

K250874 - Sunrise (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250874 · Sunrise SA · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2025
Decision
158d
Days
Class 2
Risk

K250874 is an FDA 510(k) clearance for the Sunrise. Classified as Device For Sleep Apnea Testing Based On Mandibular Movement (product code QRS), Class II - Special Controls.

Submitted by Sunrise SA (Namur, BE). The FDA issued a Cleared decision on August 29, 2025 after a review of 158 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2376 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sunrise SA devices

Submission Details

510(k) Number K250874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2025
Decision Date August 29, 2025
Days to Decision 158 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 139d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QRS Device For Sleep Apnea Testing Based On Mandibular Movement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2376
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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.