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The Tracker / August 2026 / K253699

510(k) cleared

Tempus ECG-PH

Tempus AI, Inc. · Aug 21, 2026 · K253699

FDA cleared the Tempus ECG-PH from Tempus AI, Inc. on Aug 21, 2026 under K253699, a traditional 510(k). The device falls under product code SAT, Pulmonary Hypertension Machine Learning-Based Notification Software, regulated at 21 CFR 870.2380 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Nov 24, 2025. The decision came 270 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Tempus AI, Inc. has one other decision in the tracker over the last 12 months: K241868 (xR IVD).

Questions & Answers

What did FDA clear under K253699?

K253699 is the FDA 510(k) for Tempus ECG-PH, submitted by Tempus AI, Inc.. FDA's decision date was Aug 21, 2026, under product code SAT (Pulmonary Hypertension Machine Learning-Based Notification Software).

Who makes the Tempus ECG-PH?

Tempus AI, Inc., based in Chicago, IL, is the applicant of record for K253699.

How long did the K253699 review take?

FDA received the submission on Nov 24, 2025 and issued its decision on Aug 21, 2026, 270 days later.

← All decisions in August 2026

Sources