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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 / February 2026 / K251543

510(k) cleared

Atellica® IM TSH3-Ultra II (TSH3ULII)

Siemens Healthcare Diagnostics, Inc. · Feb 6, 2026 · K251543

FDA cleared the Atellica® IM TSH3-Ultra II (TSH3ULII) from Siemens Healthcare Diagnostics, Inc. on Feb 6, 2026 under K251543, a traditional 510(k). The device falls under product code JLW, Radioimmunoassay, Thyroid-Stimulating Hormone, regulated at 21 CFR 862.1690 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on May 20, 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 K251543?

K251543 is the FDA 510(k) for Atellica® IM TSH3-Ultra II (TSH3ULII), submitted by Siemens Healthcare Diagnostics, Inc.. FDA's decision date was Feb 6, 2026, under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone).

Who makes the Atellica® IM TSH3-Ultra II (TSH3ULII)?

Siemens Healthcare Diagnostics, Inc., based in Tarrytown, NY, is the applicant of record for K251543.

How long did the K251543 review take?

FDA received the submission on May 20, 2025 and issued its decision on Feb 6, 2026, 262 days later.

← All decisions in February 2026