Cleared Traditional

xR IVD

K241868 · Tempus AI, Inc. · Pathology

Sep 2025

Decision

449d

Days

Class 2

Risk

About This 510(k) Submission

K241868 is an FDA 510(k) clearance for the xR IVD, a Next Generation Sequencing Based Tumor Profiling Test (Class II — Special Controls, product code PZM), submitted by Tempus AI, Inc. (Chicago, US). The FDA issued a Cleared decision on September 19, 2025, 449 days after receiving the submission on June 27, 2024. This device falls under the Pathology review panel. Regulated under 21 CFR 866.6080.

Submission Details

510(k) Number	K241868 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 27, 2024
Decision Date	September 19, 2025
Days to Decision	449 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	Summary PDF

Device Classification

Product Code	PZM — Next Generation Sequencing Based Tumor Profiling Test
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.6080
Definition	A Next-generation Sequencing Based Tumor Profiling Test Is A Qualitative In Vitro Diagnostic Test Intended To Detect Mutations In A Broad Panel Of Targeted Genes That Are Somatically Altered In Malignant Neoplasms From Tumor Specimens Obtained From Patients Diagnosed With Malignant Solid Neoplasms Using Targeted Next-generation Sequencing.