Cleared Traditional

K240929 - Sleep Apnea Notification Feature (SANF) (FDA 510(k) Clearance)

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

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

K240929 is an FDA 510(k) clearance for the Sleep Apnea Notification Feature (SANF). Classified as Over-the-counter Device To Assess Risk Of Sleep Apnea (product code QZW), Class II - Special Controls.

Submitted by Apple, Inc. (Cupertino, US). The FDA issued a Cleared decision on September 13, 2024 after a review of 162 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2378 - 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.

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Submission Details

510(k) Number K240929 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized Yes - Predetermined Change Control Plan authorized FDA has pre-authorized specific future modifications to this device, a pathway common in AI/SaMD devices.
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 139d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. PCCP authorized - AI/SaMD pathway.

Device Classification

Product Code QZW Over-the-counter Device To Assess Risk Of Sleep Apnea
Device Class Class 2 - 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.
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.