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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 / February 2026 / K252301

510(k) cleared

Henan Yadu Level 4 Surgical Gowns (Reinforced)

Yadu Medical (Henan) Co., Ltd. · Feb 4, 2026 · K252301

FDA cleared the Henan Yadu Level 4 Surgical Gowns (Reinforced) from Yadu Medical (Henan) Co., Ltd. on Feb 4, 2026 under K252301, 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 Jul 24, 2025. The decision came 195 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)), K250564 (Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)).

Questions & Answers

What did FDA clear under K252301?

K252301 is the FDA 510(k) for Henan Yadu Level 4 Surgical Gowns (Reinforced), submitted by Yadu Medical (Henan) Co., Ltd.. FDA's decision date was Feb 4, 2026, under product code FYA (Gown, Surgical).

Who makes the Henan Yadu Level 4 Surgical Gowns (Reinforced)?

Yadu Medical (Henan) Co., Ltd., based in He Nan, is the applicant of record for K252301.

How long did the K252301 review take?

FDA received the submission on Jul 24, 2025 and issued its decision on Feb 4, 2026, 195 days later.

← All decisions in February 2026

Sources