Cleared Traditional

Sleep Apnea Notification Feature (SANF)

K240929 · Apple, Inc. · Anesthesiology
Sep 2024
Decision
162d
Days
Class 2
Risk

About This 510(k) Submission

K240929 is an FDA 510(k) clearance for the Sleep Apnea Notification Feature (SANF), a Over-the-counter Device To Assess Risk Of Sleep Apnea (Class II — Special Controls, product code QZW), submitted by Apple, Inc. (Cupertino, US). The FDA issued a Cleared decision on September 13, 2024, 162 days after receiving the submission on April 4, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2378.

Submission Details

510(k) Number K240929 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 2024
Decision Date September 13, 2024
Days to Decision 162 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code QZW — Over-the-counter Device To Assess Risk Of Sleep Apnea
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.2378
Definition An Over-the-counter Device To Assess Risk Of Sleep Apnea Is Intended To Provide A Notification Of The Risk Of Sleep Apnea In Users Who Have Not Been Previously Diagnosed With Sleep Apnea. This Device Uses Software Algorithms To Analyze Input Sensor Signals And Provide A Risk Assessment For Sleep Apnea. It Is Not Intended To Provide A Standalone Diagnosis, Replace Traditional Methods Of Diagnosis (e.g., Polysomnography), Assist Clinicians In Diagnosing Sleep Disorders, Or Be Used As An Apnea Monitor.