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THE TAPE

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 / July 2026 / K261775

510(k) cleared

Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB)

Xuzhou Kernel Medical Equipment Co., Ltd. · Jul 21, 2026 · K261775

FDA cleared the Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB) from Xuzhou Kernel Medical Equipment Co., Ltd. on Jul 21, 2026 under K261775, a traditional 510(k). The review panel was Unknown.

FDA logged the submission as received on May 29, 2026. The decision came 53 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Xuzhou Kernel Medical Equipment Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261775?

K261775 is the FDA 510(k) for Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB), submitted by Xuzhou Kernel Medical Equipment Co., Ltd.. FDA's decision date was Jul 21, 2026.

Who makes the Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB)?

Xuzhou Kernel Medical Equipment Co., Ltd., based in Xuzhou, is the applicant of record for K261775.

How long did the K261775 review take?

FDA received the submission on May 29, 2026 and issued its decision on Jul 21, 2026, 53 days later.

← All decisions in July 2026