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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 / December 2025 / P240021

PMA approved

Atellica IM Total PSA II (tPSAII)

Siemens Healthcare Diagnostics, Inc. · Dec 3, 2025 · P240021

FDA approved the Atellica IM Total PSA II (tPSAII) from Siemens Healthcare Diagnostics, Inc. on Dec 3, 2025 under P240021, an original premarket approval. The device falls under product code MTF, Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer as a Class 3 device. The review panel was Immunology.

FDA logged the submission as received on Jun 20, 2024. The decision came 531 days later.

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 approve under P240021?

P240021 is the FDA PMA for Atellica IM Total PSA II (tPSAII), submitted by Siemens Healthcare Diagnostics, Inc.. FDA's decision date was Dec 3, 2025, under product code MTF (Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer).

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

Siemens Healthcare Diagnostics, Inc., based in Tarrytown, NY, is the applicant of record for P240021.

How long did the P240021 review take?

FDA received the submission on Jun 20, 2024 and issued its decision on Dec 3, 2025, 531 days later.

← All decisions in December 2025