Cleared Traditional

K250119 - Tempus ECG-Low EF (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K250119 is an FDA 510(k) clearance for the Tempus ECG-Low EF. Classified as Reduced Ejection Fraction Machine Learning-based Notification Software (product code QYE), Class II - Special Controls.

Submitted by Tempus AI, Inc. (Chicago, US). The FDA issued a Cleared decision on July 15, 2025 after a review of 180 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2380 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Tempus AI, Inc. devices

Submission Details

510(k) Number K250119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 125d · This submission: 180d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QYE Reduced Ejection Fraction Machine Learning-based Notification Software
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - QYE Reduced Ejection Fraction Machine Learning-based Notification Software

Devices cleared under the same product code (QYE) and FDA review panel - the closest regulatory comparables to K250119.
Bunkerhill ECG-EF
K250649 · BunkerHill Health · Sep 2025
ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)
K250652 · Anumana, Inc. · Jul 2025
Eko Low Ejection Fraction Tool (ELEFT)
K233409 · Eko Health, Inc. · Mar 2024
Low Ejection Fraction AI-ECG Algorithm
K232699 · Anumana, Inc. · Sep 2023