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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 / September 2025 / K252128

510(k) cleared

Zener® (model ZEN-001-B1)

Uvx, Inc. · Sep 15, 2025 · K252128

FDA cleared the Zener® (model ZEN-001-B1) from Uvx, Inc. on Sep 15, 2025 under K252128, a traditional 510(k) reviewed through the Third Party Review Program. The device falls under product code FRA, Purifier, Air, Ultraviolet, Medical, regulated at 21 CFR 880.6500 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Jul 7, 2025. The decision came 70 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Uvx, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252128?

K252128 is the FDA 510(k) for Zener® (model ZEN-001-B1), submitted by Uvx, Inc.. FDA's decision date was Sep 15, 2025, under product code FRA (Purifier, Air, Ultraviolet, Medical).

Who makes the Zener® (model ZEN-001-B1)?

Uvx, Inc., based in Vancouver, is the applicant of record for K252128.

How long did the K252128 review take?

FDA received the submission on Jul 7, 2025 and issued its decision on Sep 15, 2025, 70 days later.

← All decisions in September 2025