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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 / December 2025 / K250564

510(k) cleared

Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)

Yadu Medical (Henan) Co., Ltd. · Dec 3, 2025 · K250564

FDA cleared the Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) from Yadu Medical (Henan) Co., Ltd. on Dec 3, 2025 under K250564, a traditional 510(k). The device falls under product code FYA, Gown, Surgical, regulated at 21 CFR 878.4040 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Feb 26, 2025. The decision came 280 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Yadu Medical (Henan) Co., Ltd. has 2 other decisions in the tracker over the last 12 months: K261028 (Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)), K252301 (Henan Yadu Level 4 Surgical Gowns (Reinforced)).

Questions & Answers

What did FDA clear under K250564?

K250564 is the FDA 510(k) for Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL), submitted by Yadu Medical (Henan) Co., Ltd.. FDA's decision date was Dec 3, 2025, under product code FYA (Gown, Surgical).

Who makes the Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)?

Yadu Medical (Henan) Co., Ltd., based in He Nan, is the applicant of record for K250564.

How long did the K250564 review take?

FDA received the submission on Feb 26, 2025 and issued its decision on Dec 3, 2025, 280 days later.

← All decisions in December 2025

Sources