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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / September 2025 / K241868

510(k) cleared

xR IVD

Tempus AI, Inc. · Sep 19, 2025 · K241868

FDA cleared the xR IVD from Tempus AI, Inc. on Sep 19, 2025 under K241868, a traditional 510(k). The device falls under product code PZM, Next Generation Sequencing Based Tumor Profiling Test, regulated at 21 CFR 866.6080 as a Class 2 device. The review panel was Pathology.

FDA logged the submission as received on Jun 27, 2024. The decision came 449 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Tempus AI, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K241868?

K241868 is the FDA 510(k) for xR IVD, submitted by Tempus AI, Inc.. FDA's decision date was Sep 19, 2025, under product code PZM (Next Generation Sequencing Based Tumor Profiling Test).

Who makes the xR IVD?

Tempus AI, Inc., based in Chicago, IL, is the applicant of record for K241868.

How long did the K241868 review take?

FDA received the submission on Jun 27, 2024 and issued its decision on Sep 19, 2025, 449 days later.

← All decisions in September 2025