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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Next Generation Sequencing Based Tumor Profiling Test
510(k) Number K241868
Device Name xR IVD
Applicant
Tempus AI, Inc.
600 W Chicago Ave.
Suite #510
Chicago,  IL  60654
Applicant Contact Sarah Piloto
Correspondent
Tempus AI, Inc.
600 W Chicago Ave.
Suite #510
Chicago,  IL  60654
Correspondent Contact Sarah Piloto
Regulation Number866.6080
Classification Product Code
PZM  
Date Received06/27/2024
Decision Date 09/19/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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