Cleared Traditional

Tempus ECG-Low EF

K250119 · Tempus AI, Inc. · Cardiovascular
Jul 2025
Decision
180d
Days
Class 2
Risk

About This 510(k) Submission

K250119 is an FDA 510(k) clearance for the Tempus ECG-Low EF, a Reduced Ejection Fraction Machine Learning-based Notification Software (Class II — Special Controls, product code QYE), submitted by Tempus AI, Inc. (Chicago, US). The FDA issued a Cleared decision on July 15, 2025, 180 days after receiving the submission on January 16, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2380.

Submission Details

510(k) Number K250119 FDA.gov
FDA Decision Cleared SESE
Date Received January 16, 2025
Decision Date July 15, 2025
Days to Decision 180 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code QYE — Reduced Ejection Fraction Machine Learning-based Notification Software
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2380
Definition Reduced Ejection Fraction Machine Learning-based Notification Software Employs Machine Learning Techniques To Suggest The Likelihood Of A Reduced Ejection Fraction For Further Referral Or Diagnostic Follow-up.