Tempus ECG-AF is an AI-enabled medical device from Tempus AI, Inc. that the U.S. FDA cleared through 510(k) K233549 on June 21, 2024. Its lead review panel is Cardiovascular and its primary product code is SBQ (Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software).
See also FDA-cleared AI cardiovascular devices in 2024, all FDA AI clearances in 2024, top cardiovascular AI devices.
Key facts
| Submission number | K233549 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Tempus AI, Inc. |
| Lead review panel | Cardiovascular |
| Primary product code | SBQ — Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software |
| Applicant (openFDA) | Tempus AI, Inc. |
| Applicant location | Chicago, IL, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 870.2380 |
| 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. Tempus ECG-AF went through this pathway (K233549).
openFDA lists it as a Class 2 device under 21 CFR 870.2380. Class II devices are moderate risk and are subject to general and special controls.
Product code SBQ covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. Tempus AI, Inc. has 2 AI-enabled devices on the list, and the Cardiovascular panel accounts for 154 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.