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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 / March 2026 / K252534

510(k) cleared

Surgical Face Mask (Ear mount)

Zhejiang Hangkang Medical Equipment Co., Ltd. · Mar 3, 2026 · K252534

FDA cleared the Surgical Face Mask (Ear mount) from Zhejiang Hangkang Medical Equipment Co., Ltd. on Mar 3, 2026 under K252534, a traditional 510(k). The device falls under product code FXX, Mask, 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 Aug 12, 2025. The decision came 203 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 Zhejiang Hangkang Medical Equipment Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252534?

K252534 is the FDA 510(k) for Surgical Face Mask (Ear mount), submitted by Zhejiang Hangkang Medical Equipment Co., Ltd.. FDA's decision date was Mar 3, 2026, under product code FXX (Mask, Surgical).

Who makes the Surgical Face Mask (Ear mount)?

Zhejiang Hangkang Medical Equipment Co., Ltd., based in Yiwu, is the applicant of record for K252534.

How long did the K252534 review take?

FDA received the submission on Aug 12, 2025 and issued its decision on Mar 3, 2026, 203 days later.

← All decisions in March 2026