# K253699: Tempus ECG-PH

- Pathway: 510(k) (Traditional)
- Applicant: Tempus AI, Inc.
- Decided: Aug 21, 2026 after 270 days
- Product code: SAT (Pulmonary Hypertension 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: 3 generations back to DEN230003 (2023). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233666: CorVista System with PH Add-On, Analytics For Life, Inc. (2024) Summary page 5.

## Indications for use
Tempus ECG-PH is software intended to analyze resting, non-ambulatory 12-lead ECG recordings and detect signs associated with a patient having elevated mean pulmonary artery pressure (mPAP > 20 mmHg), an indicator of pulmonary hypertension (PH). It is for use on clinical diagnostic 12-lead ECG recordings collected at a healthcare facility from patients: • 40 years of age or older • with cardiovascular symptoms (dyspnea, fatigue, chest pain, or edema) • who do not have a known history of PH Tempus ECG-PH only analyzes ECG data and provides a binary output for interpretation. Tempus ECG-PH is not intended to be a stand-alone diagnostic tool for PH, should not be used for serial patient monitoring, and should not be used on ECGs with paced rhythms. Results should always be interpreted in conjunction with other diagnostic information, including the patient’s original ECG recordings, as well as the patient’s symptoms, other tests, and clinical history.

Source page: https://510kreport.com/device/K253699
Methodology: https://510kreport.com/methodology