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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 / K251037

510(k) cleared

Rectal Applicator

Nucletron B.V. · Dec 19, 2025 · K251037

FDA cleared the Rectal Applicator from Nucletron B.V. on Dec 19, 2025 under K251037, a traditional 510(k). The device falls under product code JAQ, System, Applicator, Radionuclide, Remote-Controlled, regulated at 21 CFR 892.5700 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Apr 3, 2025. The decision came 260 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Nucletron B.V. has one other decision in the tracker over the last 12 months: K262383 (LumenCare Azure).

Questions & Answers

What did FDA clear under K251037?

K251037 is the FDA 510(k) for Rectal Applicator, submitted by Nucletron B.V.. FDA's decision date was Dec 19, 2025, under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled).

Who makes the Rectal Applicator?

Nucletron B.V., based in Veenendaal, is the applicant of record for K251037.

How long did the K251037 review take?

FDA received the submission on Apr 3, 2025 and issued its decision on Dec 19, 2025, 260 days later.

← All decisions in December 2025

Sources