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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 / K243864

510(k) cleared

BONX805

Bontech Co., Ltd. · Sep 12, 2025 · K243864

FDA cleared the BONX805 from Bontech Co., Ltd. on Sep 12, 2025 under K243864, a traditional 510(k). The device falls under product code IZL, System, X-Ray, Mobile, regulated at 21 CFR 892.1720 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Dec 17, 2024. The decision came 269 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 Bontech Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K243864?

K243864 is the FDA 510(k) for BONX805, submitted by Bontech Co., Ltd.. FDA's decision date was Sep 12, 2025, under product code IZL (System, X-Ray, Mobile).

Who makes the BONX805?

Bontech Co., Ltd., based in Suwon-Si, is the applicant of record for K243864.

How long did the K243864 review take?

FDA received the submission on Dec 17, 2024 and issued its decision on Sep 12, 2025, 269 days later.

← All decisions in September 2025