Sleep Apnea Notification Feature (SANF) is an AI-enabled medical device from Apple Inc. that the U.S. FDA cleared through 510(k) K240929 on September 13, 2024. Its lead review panel is Anesthesiology and its primary product code is QZW (Over-The-Counter Device To Assess Risk Of Sleep Apnea).
See also FDA-cleared AI anesthesiology devices in 2024, all FDA AI clearances in 2024, top anesthesiology AI devices.
Key facts
| Submission number | K240929 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Apple Inc. |
| Lead review panel | Anesthesiology |
| Primary product code | QZW — Over-The-Counter Device To Assess Risk Of Sleep Apnea |
| Applicant (openFDA) | Apple, Inc. |
| Applicant location | Cupertino, CA, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 868.2378 |
| Decision code | SESE |
| Submission type | Traditional |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. Sleep Apnea Notification Feature (SANF) went through this pathway (K240929).
openFDA lists it as a Class 2 device under 21 CFR 868.2378. Class II devices are moderate risk and are subject to general and special controls.
Product code QZW covers 2 devices on the FDA AI list. By decision date, this device is #2 of 2 under that code. Apple Inc. has 5 AI-enabled devices on the list, and the Anesthesiology panel accounts for 30 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.