# K233549: Tempus ECG-AF

- Pathway: 510(k) (Traditional)
- Applicant: Tempus AI, Inc.
- Decided: Jun 21, 2024 after 231 days
- Product code: SBQ (Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software)
- Device class: 2
- Regulation: 21 CFR 870.2380
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN230003 (2023). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN230003: Viz HCM, Viz. Ai, Inc. (2023) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K233549
Methodology: https://510kreport.com/methodology