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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 / July 2026 / K261364

510(k) cleared

Atellica CH Acetaminophen 2 (ACTM)

Siemens Healthcare Diagnostics, Inc. · Jul 24, 2026 · K261364

FDA cleared the Atellica CH Acetaminophen 2 (ACTM) from Siemens Healthcare Diagnostics, Inc. on Jul 24, 2026 under K261364, a traditional 510(k). The device falls under product code LDP, Colorimetry, Acetaminophen, regulated at 21 CFR 862.3030 as a Class 2 device. The review panel was Clinical Toxicology.

FDA logged the submission as received on Apr 27, 2026. The decision came 88 days later, inside the 90 FDA-day goal for a 510(k).

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), K253264 (myAblation Guide (VC10A)), P250026 (Atellica IM free PSA II (fPSAII)).

Questions & Answers

What did FDA clear under K261364?

K261364 is the FDA 510(k) for Atellica CH Acetaminophen 2 (ACTM), submitted by Siemens Healthcare Diagnostics, Inc.. FDA's decision date was Jul 24, 2026, under product code LDP (Colorimetry, Acetaminophen).

Who makes the Atellica CH Acetaminophen 2 (ACTM)?

Siemens Healthcare Diagnostics, Inc., based in Tarrytown, NY, is the applicant of record for K261364.

How long did the K261364 review take?

FDA received the submission on Apr 27, 2026 and issued its decision on Jul 24, 2026, 88 days later.

← All decisions in July 2026