FDA.reportPublic FDA data

510(k) K253699

Device
Tempus ECG-PH
Applicant
Tempus AI, Inc.
510(k) number
K253699
Product code
SAT
Decision
Substantially Equivalent (SESE)
Decision date
2026-08-21
Date received
2025-11-24
Regulation
870.2380
Classification name
Pulmonary Hypertension Machine Learning-Based Notification Software
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Bethany Barrett
Address
600 W Chicago Ave. Suite #510 Chicago IL US 60654 60654

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code SAT#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252360ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)Anumana, Inc.2026-03-28
K233666CorVista System with PH Add-OnAnalytics For Life, Inc.2024-04-05