510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253699Substantially Equivalent

Tempus ECG-PH

Tempus AI, Inc., Chicago IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253699 is the FDA 510(k) clearance record for Tempus ECG-PH, a class II device, cleared for Tempus AI, Inc. on under FDA product code SAT (Pulmonary Hypertension Machine Learning-Based Notification Software). FDA's definition for product code SAT reads: "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". As of , FDA records show no recalls naming K253699.

Clearance record

Decision date
Received
(270 days to decision)
Product code
SAT Pulmonary Hypertension Machine Learning-Based Notification Software
Regulation
21 CFR 870.2380
Device class
Class II
Review panel
Cardiovascular
Applicant
Tempus AI, Inc. 600 W Chicago Ave., Chicago IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SAT

Trailing 12 months
2 clearances under product code SAT in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SAT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260