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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 / April 2026 / K253446

510(k) cleared

AeroDR TX c02

Dk Medical Systems Co., Ltd. · Apr 10, 2026 · K253446

FDA cleared the AeroDR TX c02 from Dk Medical Systems Co., Ltd. on Apr 10, 2026 under K253446, a traditional 510(k). The device falls under product code KPR, System, X-Ray, Stationary, regulated at 21 CFR 892.1680 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Oct 2, 2025. The decision came 190 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Dk Medical Systems Co., Ltd. has 8 other decisions in the tracker over the last 12 months: K253808 (AIR Recon DL), K253667 (Accoat Guide Wire), K254130 (C.A. Medical Interbody Fusion System), K253317 (Cytrans Elashield).

Questions & Answers

What did FDA clear under K253446?

K253446 is the FDA 510(k) for AeroDR TX c02, submitted by Dk Medical Systems Co., Ltd.. FDA's decision date was Apr 10, 2026, under product code KPR (System, X-Ray, Stationary).

Who makes the AeroDR TX c02?

Dk Medical Systems Co., Ltd., based in Pyeongtaek-Si, is the applicant of record for K253446.

How long did the K253446 review take?

FDA received the submission on Oct 2, 2025 and issued its decision on Apr 10, 2026, 190 days later.

← All decisions in April 2026