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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 / K252223

510(k) cleared

Alpha Endo Handpiece (Alpha Endo)

SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. · Oct 16, 2025 · K252223

FDA cleared the Alpha Endo Handpiece (Alpha Endo) from SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. on Oct 16, 2025 under K252223, a traditional 510(k). The device falls under product code EKX, Handpiece, Direct Drive, Ac-Powered, regulated at 21 CFR 872.4200 as a Class 1 device. The review panel was Dental.

FDA logged the submission as received on Jul 16, 2025. The decision came 92 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 SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252223?

K252223 is the FDA 510(k) for Alpha Endo Handpiece (Alpha Endo), submitted by SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.. FDA's decision date was Oct 16, 2025, under product code EKX (Handpiece, Direct Drive, Ac-Powered).

Who makes the Alpha Endo Handpiece (Alpha Endo)?

SHENZHEN SUPERLINE TECHNOLOGY CO., LTD., based in Shenzhen, is the applicant of record for K252223.

How long did the K252223 review take?

FDA received the submission on Jul 16, 2025 and issued its decision on Oct 16, 2025, 92 days later.

← All decisions in October 2025