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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 / K251894

510(k) cleared

Himaging Bronchscope System

Himaging Technology (Shanghai) Co., Ltd. · Sep 23, 2025 · K251894

FDA cleared the Himaging Bronchscope System from Himaging Technology (Shanghai) Co., Ltd. on Sep 23, 2025 under K251894, a traditional 510(k). The device falls under product code EOQ, Bronchoscope (Flexible Or Rigid), regulated at 21 CFR 874.4680 as a Class 2 device. The review panel was Ear, Nose, Throat.

FDA logged the submission as received on Jun 20, 2025. The decision came 95 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 Himaging Technology (Shanghai) Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251894?

K251894 is the FDA 510(k) for Himaging Bronchscope System, submitted by Himaging Technology (Shanghai) Co., Ltd.. FDA's decision date was Sep 23, 2025, under product code EOQ (Bronchoscope (Flexible Or Rigid)).

Who makes the Himaging Bronchscope System?

Himaging Technology (Shanghai) Co., Ltd., based in Shanghai, is the applicant of record for K251894.

How long did the K251894 review take?

FDA received the submission on Jun 20, 2025 and issued its decision on Sep 23, 2025, 95 days later.

← All decisions in September 2025