Tempus ECG-PH

FDA 510(k) K253699 · Tempus AI, Inc.

Substantially Equivalent

510(k) numberK253699

Submission

Device name
Tempus ECG-PH
Applicant
Tempus AI, Inc.
Chicago, IL, US
Received
November 24, 2025
Decision date
August 21, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
SAT – Pulmonary Hypertension Machine Learning-Based Notification Software
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2380
Specialty
Cardiovascular

Pulmonary hypertension machine learning-based notification software employs machine learning techniques to suggest the likelihood of pulmonary hypertension for further referral or diagnostic follow-up.

Other 510(k)s with product code SAT

510(k)DeviceApplicantDecision
K252360ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)SAT · Traditional Anumana, Inc.03/28/2026SE
K233666CorVista System with PH Add-OnSAT · Traditional Analytics For Life, Inc.04/05/2024SE

More from Analytics For Life, Inc.

510(k)DeviceDecision
K241868xR IVDPZM · Traditional 09/19/2025SE
K250119Tempus ECG-Low EFQYE · Traditional 07/15/2025SE
K233549Tempus ECG-AFSBQ · Traditional 06/21/2024SE

Questions and answers

When was Tempus ECG-PH cleared by the FDA?

Tempus ECG-PH (K253699) received a 510(k) decision of Substantially Equivalent on August 21, 2026, 270 days after the submission was received.

What is the product code of K253699?

The FDA product code is SAT – Pulmonary Hypertension Machine Learning-Based Notification Software, a Class II (moderate risk) device regulated under 21 CFR 870.2380.