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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 / K244038

510(k) cleared

High Pressure Tubing

Shandong Int Medical Instruments Co., Ltd. · Sep 5, 2025 · K244038

FDA cleared the High Pressure Tubing from Shandong Int Medical Instruments Co., Ltd. on Sep 5, 2025 under K244038, a traditional 510(k). The device falls under product code DXT, Injector And Syringe, Angiographic, regulated at 21 CFR 870.1650 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Dec 30, 2024. The decision came 249 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 Shandong Int Medical Instruments Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K244038?

K244038 is the FDA 510(k) for High Pressure Tubing, submitted by Shandong Int Medical Instruments Co., Ltd.. FDA's decision date was Sep 5, 2025, under product code DXT (Injector And Syringe, Angiographic).

Who makes the High Pressure Tubing?

Shandong Int Medical Instruments Co., Ltd., based in Shandong, is the applicant of record for K244038.

How long did the K244038 review take?

FDA received the submission on Dec 30, 2024 and issued its decision on Sep 5, 2025, 249 days later.

← All decisions in September 2025