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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 / January 2026 / K252830

510(k) cleared

Disposable Surgical Face Mask (3P00B, C2900)

Beatles Medical Supplies (Xiantao) Co., Ltd. · Jan 12, 2026 · K252830

FDA cleared the Disposable Surgical Face Mask (3P00B, C2900) from Beatles Medical Supplies (Xiantao) Co., Ltd. on Jan 12, 2026 under K252830, 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 Sep 5, 2025. The decision came 129 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 Beatles Medical Supplies (Xiantao) Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252830?

K252830 is the FDA 510(k) for Disposable Surgical Face Mask (3P00B, C2900), submitted by Beatles Medical Supplies (Xiantao) Co., Ltd.. FDA's decision date was Jan 12, 2026, under product code FXX (Mask, Surgical).

Who makes the Disposable Surgical Face Mask (3P00B, C2900)?

Beatles Medical Supplies (Xiantao) Co., Ltd., based in Xiantao, is the applicant of record for K252830.

How long did the K252830 review take?

FDA received the submission on Sep 5, 2025 and issued its decision on Jan 12, 2026, 129 days later.

← All decisions in January 2026