Sleep Apnea Notification Feature (SANF)
FDA 510(k) K240929 · Apple, Inc.
Submission
- Device name
- Sleep Apnea Notification Feature (SANF)
- Applicant
- Apple, Inc.
Cupertino, CA, US - Received
- April 4, 2024
- Decision date
- September 13, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QZW – Over-The-Counter Device To Assess Risk Of Sleep Apnea
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2378
- Specialty
- Anesthesiology
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…
Other 510(k)s with product code QZW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261011 | Sleep Apnea Feature (v2.0)QZW · Traditional | Samsung Electronics Co., Ltd. | 07/20/2026SE |
More from Samsung Electronics Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K253582 | Medical Imaging Calibration Feature (MICF)SHN · Traditional | 04/01/2026SE |
| K250507 | Hypertension Notification Feature (HTNF)SFR · Traditional | 09/11/2025SE |
| K250143 | Digital Prism Correction Feature (DPCF)SCW · Traditional | 06/23/2025SE |
| K242058 | Digital Prism Correction Feature (DPCF)SCW · Traditional | 10/21/2024SE |
| K231173 | Irregular Rhythm Notification Feature (IRNF)QDB · Traditional | 07/21/2023SE |
| K213971 | Atrial Fibrillation History FeatureQDB · Traditional | 06/03/2022SE |
| K212516 | IRNF AppQDB · Traditional | 10/22/2021SE |
| K201525 | ECG AppQDA · Traditional | 10/08/2020SE |
Questions and answers
When was Sleep Apnea Notification Feature (SANF) cleared by the FDA?
Sleep Apnea Notification Feature (SANF) (K240929) received a 510(k) decision of Substantially Equivalent on September 13, 2024, 162 days after the submission was received.
What is the product code of K240929?
The FDA product code is QZW – Over-The-Counter Device To Assess Risk Of Sleep Apnea, a Class II (moderate risk) device regulated under 21 CFR 868.2378.