FDA 510(k) · Tempus AI
K254297: Tempus ECG-MR (Tempus AI, Inc.)
Tempus AI, Inc. received FDA 510(k) K254297 for Tempus ECG-MR, with a decision date of Sep 25, 2026 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K254297 |
|---|---|
| Pathway | 510(k) |
| Applicant | Tempus AI, Inc. |
| Device name | Tempus ECG-MR |
| Product code | SBQ: Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software |
| Regulation (21 CFR) | 870.2380 |
| Device class | Class 2 |
| Date received | Dec 31, 2025 |
| Decision date | Sep 25, 2026 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
Tempus ECG-MR is software intended to analyze resting, non-ambulatory 12-lead ECG recordings and detect signs associated with having moderate or severe mitral regurgitation (MR). It is for use on clinical diagnostic ECG recordings collected at a healthcare facility from patients: • 65 years of age or older • At risk of cardiovascular disease. Such cardiovascular risk factors include, but are not limited to, history of coronary artery disease, hypertension, obesity, or diabetes; or other signs or symptoms of heart disease, such as dyspnea, chest pain, or lower extremity edema. • Without prior mitral valve intervention • Without prior diagnosis of moderate or severe mitral regurgitation Tempus ECG-MR only analyzes ECG data and provides a binary output for interpretation. Tempus ECG-MR is not intended to be a stand-alone diagnostic tool for cardiac conditions, should not be used for serial patient monitoring, and should not be used on ECGs with paced rhythms. Results should be interpreted in conjunction with other diagnostic information, including the patient’s original ECG recordings and other tests, as well as the patient’s symptoms and clinical history.
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code SBQ is "Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software", class 2, 21 CFR 870.2380. FDA's definition: "Atrial Fibrillation Risk Prediction machine learning-based notification software employs machine learning techniques to suggest the likelihood of a future occurrence of atrial fibrillation for further referral or diagnostic follow-up."
Our labels for filtering: claim AFib / irregular rhythm, sensor ECG electrodes. These are heuristics, not FDA fields.