WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / August 2026 / K261028

510(k) cleared

Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)

Yadu Medical (Henan) Co., Ltd. · Aug 7, 2026 · K261028

FDA cleared the Surgical Gown Level2 (S, M, L, XL, XXL, XXXL) from Yadu Medical (Henan) Co., Ltd. on Aug 7, 2026 under K261028, 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 Mar 30, 2026. The decision came 130 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: K252301 (Henan Yadu Level 4 Surgical Gowns (Reinforced)), K250564 (Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)).

Questions & Answers

What did FDA clear under K261028?

K261028 is the FDA 510(k) for Surgical Gown Level2 (S, M, L, XL, XXL, XXXL), submitted by Yadu Medical (Henan) Co., Ltd.. FDA's decision date was Aug 7, 2026, under product code FYA (Gown, Surgical).

Who makes the Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)?

Yadu Medical (Henan) Co., Ltd., based in He Nan, is the applicant of record for K261028.

How long did the K261028 review take?

FDA received the submission on Mar 30, 2026 and issued its decision on Aug 7, 2026, 130 days later.

← All decisions in August 2026

Sources