Sleep Apnea Notification Feature (SANF)

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K240929Ref Sleep Apnea Notification Feature 1.X

by Apple Inc.

Identity

Trade Name: Sleep Apnea Notification Feature (SANF) FDA UDI
Generic Name: Self-care monitoring/reporting software FDA UDI
Device Name: Sleep Apnea Notification Feature EUDAMED
Sleep Apnea Notification Feature WatchOS (version 1.X) FDA UDI
Model / Reference: Sleep Apnea Notification Feature 1.X EUDAMED
Feature version 1.X FDA UDI
Description: Sleep Apnea Notification Feature WatchOS (version 1.X) FDA UDI

Identifiers

Primary DI / UDI-DI: 00195949116193 EUDAMEDFDA UDI
Basic UDI-DI: 0195949SANF55 EUDAMED
Direct Marketing DI: 00195949116193 EUDAMED
510(k) Number: K240929 FDA 510(k)FDA UDI
FDA Product Code: QZW FDA 510(k)FDA UDI
EMDN Code: Z12039092 VARIOUS INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS - MEDICAL DEVICE SOFTWARE EUDAMED
GMDN Term: Self-care monitoring/reporting software FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework: 21 CFR Part 868.2378 FDA 510(k)
Regulation Number: 868.2378 FDA 510(k)FDA UDI
Special Device Type: Software EUDAMED
Market of Registration: Germany EUDAMED
Advisory Committee: Anesthesiology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

The Sleep Apnea Notification Feature (SANF) is an Over-the-Counter Device designed to assess the risk of sleep apnea, as classified under FDA regulation 868.2378. It provides users with notifications based on monitored data to help identify potential sleep apnea symptoms, functioning as a screening tool rather than a diagnostic device.

This feature is integrated into a digital platform and is intended for home use, requiring no specialized medical setting or sterility. It operates as a single-use application per assessment cycle, with no reusable components. The device adheres to FDA clearance under 510(k) classification, with no explicit MRI safety or size specifications provided. Storage and usage are governed by the manufacturer’s software guidelines, and its regulatory status includes FDA 510(k) clearance and EU MDR compliance.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K240929	Class II	Active

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Manufacturer

Manufacturer: Apple Inc.
FDA Applicant: Apple, Inc.

Sources (3)

FDA 510(k) K240929 24 fields · synced Sep 18, 2026
FDA UDI 9035b761-79de-4905-a61d-aeb4e5835032 34 fields · synced May 30, 2026
EUDAMED 375b2207-0938-42f6-9733-86cb1b3f6e50 61 fields · synced Jul 13, 2026