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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 / January 2026 / K251630

510(k) cleared

Atellica IM Total PSA II (tPSAII)

Siemens Healthcare Diagnostics, Inc. · Jan 5, 2026 · K251630

FDA cleared the Atellica IM Total PSA II (tPSAII) from Siemens Healthcare Diagnostics, Inc. on Jan 5, 2026 under K251630, a traditional 510(k). The device falls under product code LTJ, Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers, regulated at 21 CFR 866.6010 as a Class 2 device. The review panel was Immunology.

FDA logged the submission as received on May 28, 2025. The decision came 222 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 K251630?

K251630 is the FDA 510(k) for Atellica IM Total PSA II (tPSAII), submitted by Siemens Healthcare Diagnostics, Inc.. FDA's decision date was Jan 5, 2026, under product code LTJ (Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers).

Who makes the Atellica IM Total PSA II (tPSAII)?

Siemens Healthcare Diagnostics, Inc., based in Tarrytown, NY, is the applicant of record for K251630.

How long did the K251630 review take?

FDA received the submission on May 28, 2025 and issued its decision on Jan 5, 2026, 222 days later.

← All decisions in January 2026