FDA 510(k) · Tempus AI
K233549: Tempus ECG-AF (Tempus AI, Inc.)
Tempus AI, Inc. received FDA 510(k) K233549 for Tempus ECG-AF, with a decision date of Jun 21, 2024 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K233549 |
|---|---|
| Pathway | 510(k) |
| Applicant | Tempus AI, Inc. |
| Device name | Tempus ECG-AF |
| Product code | SBQ: Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software |
| Regulation (21 CFR) | 870.2380 |
| Device class | Class 2 |
| Date received | Nov 3, 2023 |
| Decision date | Jun 21, 2024 |
| 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-AF is intended for use to analyze recordings of 12-lead ECG devices and detect signs associated with a patient experiencing atrial fibrillation and/or atrial flutter (collectively referred to as AF) within the next 12 months. It is for use on resting 12-lead ECG recordings collected at a healthcare facility from patients: • 65 years of age or older, • without pre-existing or concurrent documentation of atrial fibrillation and/or atrial flutter, • who do not have a pacemaker or implantable cardioverter defibrillator, and • who did not have cardiac surgery within the preceding 30 days. Performance of repeated testing of the same patient over time has not been evaluated and results SHOULD NOT be used for patient monitoring. Tempus ECG-AF only analyzes ECG data. 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. Tempus ECG-AF is not for use in patients with a history of AF, unless the AF occurred after a cardiac surgery procedure and resolved within 30 days of the procedure. It is not for use to assess risk of occurrence of AF related to cardiac surgery. Results do not describe a person’s overall risk of experiencing AF or serve as the sole basis for diagnosis of AF, and should not be used as the basis for treatment of AF. Results are not intended to rule out AF follow-up.
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.
- DEN230003 Viz HCM (Viz.ai)
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.