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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 / October 2025 / K250083

510(k) cleared

PRO-DOSE System

Nu-Rise, SA · Oct 1, 2025 · K250083

FDA cleared the PRO-DOSE System from Nu-Rise, SA on Oct 1, 2025 under K250083, a traditional 510(k). The device falls under product code NZT, Dosimeter, Ionizing Radiation, Implanted, regulated at 21 CFR 892.5050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jan 13, 2025. The decision came 261 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Nu-Rise, SA in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250083?

K250083 is the FDA 510(k) for PRO-DOSE System, submitted by Nu-Rise, SA. FDA's decision date was Oct 1, 2025, under product code NZT (Dosimeter, Ionizing Radiation, Implanted).

Who makes the PRO-DOSE System?

Nu-Rise, SA, based in Ilhavo, is the applicant of record for K250083.

How long did the K250083 review take?

FDA received the submission on Jan 13, 2025 and issued its decision on Oct 1, 2025, 261 days later.

← All decisions in October 2025