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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 / K250242

510(k) cleared

Compression Therapy Device (LGT-2202DVT)

Guangzhou Longest Medical Technology Co., Ltd. · Apr 24, 2026 · K250242

FDA cleared the Compression Therapy Device (LGT-2202DVT) from Guangzhou Longest Medical Technology Co., Ltd. on Apr 24, 2026 under K250242, a traditional 510(k). The device falls under product code JOW, Sleeve, Limb, Compressible, regulated at 21 CFR 870.5800 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jan 27, 2025. The decision came 452 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Guangzhou Longest Medical Technology Co., Ltd. has one other decision in the tracker over the last 12 months: K252154 (Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)).

Questions & Answers

What did FDA clear under K250242?

K250242 is the FDA 510(k) for Compression Therapy Device (LGT-2202DVT), submitted by Guangzhou Longest Medical Technology Co., Ltd.. FDA's decision date was Apr 24, 2026, under product code JOW (Sleeve, Limb, Compressible).

Who makes the Compression Therapy Device (LGT-2202DVT)?

Guangzhou Longest Medical Technology Co., Ltd., based in Guangzhou, is the applicant of record for K250242.

How long did the K250242 review take?

FDA received the submission on Jan 27, 2025 and issued its decision on Apr 24, 2026, 452 days later.

← All decisions in April 2026

Sources