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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 / January 2026 / K251354

510(k) cleared

UV Smart D60

UV Smart Technologies B.V. · Jan 29, 2026 · K251354

FDA cleared the UV Smart D60 from UV Smart Technologies B.V. on Jan 29, 2026 under K251354, a traditional 510(k). The device falls under product code SCS, Ultraviolet Radiation Disinfection Chamber Device, regulated at 21 CFR 880.6511 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Apr 30, 2025. The decision came 274 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 UV Smart Technologies B.V. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251354?

K251354 is the FDA 510(k) for UV Smart D60, submitted by UV Smart Technologies B.V.. FDA's decision date was Jan 29, 2026, under product code SCS (Ultraviolet Radiation Disinfection Chamber Device).

Who makes the UV Smart D60?

UV Smart Technologies B.V., based in Rijswijk, is the applicant of record for K251354.

How long did the K251354 review take?

FDA received the submission on Apr 30, 2025 and issued its decision on Jan 29, 2026, 274 days later.

← All decisions in January 2026