Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Tempus ECG-Low EF

K-Number: K250119 · 2025-07-15

ApplicantTempus AI, Inc.
Decision Date2025-07-15
Product CodeQYE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Tempus ECG-Low EF is the device name listed in this FDA 510(k) record. The listed applicant is Tempus AI, Inc.. It received FDA 510(k) clearance on 2025-07-15 under 510(k) number K250119. The device is classified under product code QYE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tempus ECG-Low EF?

Tempus ECG-Low EF is a medical device that received FDA 510(k) clearance on 2025-07-15. The listed applicant is Tempus AI, Inc.. The 510(k) number is K250119.

When did Tempus ECG-Low EF receive FDA 510(k) clearance?

Tempus ECG-Low EF received FDA 510(k) clearance on 2025-07-15, under 510(k) number K250119.

Who is the listed applicant for Tempus ECG-Low EF?

The FDA 510(k) record lists Tempus AI, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tempus ECG-Low EF?

The FDA product code for Tempus ECG-Low EF is QYE.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06511505NOrthwestern Tempus AI-enaBLed Electrocardiography (NOTABLE) TrialRECRUITINGNCT06911632Multi-site Study of the Clinical Impact of an AI-assisted Approach to Referring Patients With Interstitial Lung Disease for Diagnostic Evaluation of Pulmonary HypertensionRECRUITING

Other records listing Tempus AI, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241868xR IVDK233549Tempus ECG-AF

Related Devices (Code: QYE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250649Bunkerhill ECG-EFBunkerHill HealthK250652ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)Anumana, Inc.K233409Eko Low Ejection Fraction Tool (ELEFT)Eko Health, Inc.K232699Low Ejection Fraction AI-ECG AlgorithmAnumana, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑