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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 / May 2026 / K252591

510(k) cleared

Automatic Micro Needle System (CODE-X)

Woorhi Mechatronics Co., Ltd. · May 13, 2026 · K252591

FDA cleared the Automatic Micro Needle System (CODE-X) from Woorhi Mechatronics Co., Ltd. on May 13, 2026 under K252591, a traditional 510(k). The device falls under product code QAI, Powered Microneedle Device, regulated at 21 CFR 878.4430 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Aug 15, 2025. The decision came 271 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 Woorhi Mechatronics Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252591?

K252591 is the FDA 510(k) for Automatic Micro Needle System (CODE-X), submitted by Woorhi Mechatronics Co., Ltd.. FDA's decision date was May 13, 2026, under product code QAI (Powered Microneedle Device).

Who makes the Automatic Micro Needle System (CODE-X)?

Woorhi Mechatronics Co., Ltd., based in Gunpo-Si, is the applicant of record for K252591.

How long did the K252591 review take?

FDA received the submission on Aug 15, 2025 and issued its decision on May 13, 2026, 271 days later.

← All decisions in May 2026