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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 / K251998

510(k) cleared

Atellica CH Diazo Total Bilirubin (D_TBil)

Siemens Healthcare Diagnostics, Inc. · Feb 27, 2026 · K251998

FDA cleared the Atellica CH Diazo Total Bilirubin (D_TBil) from Siemens Healthcare Diagnostics, Inc. on Feb 27, 2026 under K251998, a traditional 510(k). The device falls under product code CIG, Diazo Colorimetry, Bilirubin, regulated at 21 CFR 862.1110 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Jun 27, 2025. The decision came 245 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 K251998?

K251998 is the FDA 510(k) for Atellica CH Diazo Total Bilirubin (D_TBil), submitted by Siemens Healthcare Diagnostics, Inc.. FDA's decision date was Feb 27, 2026, under product code CIG (Diazo Colorimetry, Bilirubin).

Who makes the Atellica CH Diazo Total Bilirubin (D_TBil)?

Siemens Healthcare Diagnostics, Inc., based in Newark, DE, is the applicant of record for K251998.

How long did the K251998 review take?

FDA received the submission on Jun 27, 2025 and issued its decision on Feb 27, 2026, 245 days later.

← All decisions in February 2026