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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 / October 2025 / K250250

510(k) cleared

ADVIA Centaur Anti-Thyroid Peroxidase II

Siemens Healthcare Diagnostics, Inc. · Oct 17, 2025 · K250250

FDA cleared the ADVIA Centaur Anti-Thyroid Peroxidase II from Siemens Healthcare Diagnostics, Inc. on Oct 17, 2025 under K250250, a traditional 510(k). The device falls under product code JZO, System, Test, Thyroid Autoantibody, regulated at 21 CFR 866.5870 as a Class 2 device. The review panel was Immunology.

FDA logged the submission as received on Jan 28, 2025. The decision came 262 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Siemens Healthcare Diagnostics, Inc. has 8 other decisions in the tracker over the last 12 months: K253985 (INNOVANCE® D-Dimer 2.0 (SMN 10873803)), K253528 (Atellica IM CA 19-9 II), K261364 (Atellica CH Acetaminophen 2 (ACTM)), K253264 (myAblation Guide (VC10A)).

Questions & Answers

What did FDA clear under K250250?

K250250 is the FDA 510(k) for ADVIA Centaur Anti-Thyroid Peroxidase II, submitted by Siemens Healthcare Diagnostics, Inc.. FDA's decision date was Oct 17, 2025, under product code JZO (System, Test, Thyroid Autoantibody).

Who makes the ADVIA Centaur Anti-Thyroid Peroxidase II?

Siemens Healthcare Diagnostics, Inc., based in Tarrytown, NY, is the applicant of record for K250250.

How long did the K250250 review take?

FDA received the submission on Jan 28, 2025 and issued its decision on Oct 17, 2025, 262 days later.

← All decisions in October 2025