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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 / April 2026 / K252431

510(k) cleared

Elecsys Calcitonin

Roche Diagnostics GmbH · Apr 24, 2026 · K252431

FDA cleared the Elecsys Calcitonin from Roche Diagnostics GmbH on Apr 24, 2026 under K252431, a traditional 510(k). The device falls under product code JKR, Radioimmunoassay, Calcitonin, regulated at 21 CFR 862.1140 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Aug 1, 2025. The decision came 266 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Roche Diagnostics GmbH has 8 other decisions in the tracker over the last 12 months: K252323 (cobas pulse blood glucose monitoring system), K252280 (Elecsys Anti-SARS-CoV-2 S), K260046 (Elecsys Anti-HBc II), K260048 (Elecsys Anti-HAV IgM).

Questions & Answers

What did FDA clear under K252431?

K252431 is the FDA 510(k) for Elecsys Calcitonin, submitted by Roche Diagnostics GmbH. FDA's decision date was Apr 24, 2026, under product code JKR (Radioimmunoassay, Calcitonin).

Who makes the Elecsys Calcitonin?

Roche Diagnostics GmbH, based in Mannheim, is the applicant of record for K252431.

How long did the K252431 review take?

FDA received the submission on Aug 1, 2025 and issued its decision on Apr 24, 2026, 266 days later.

← All decisions in April 2026