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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 / K243342

510(k) cleared

KP Protective Face Mask

Kp Trading Co., Ltd. · Dec 22, 2025 · K243342

FDA cleared the KP Protective Face Mask from Kp Trading Co., Ltd. on Dec 22, 2025 under K243342, 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 Oct 25, 2024. The decision came 423 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 Kp Trading Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K243342?

K243342 is the FDA 510(k) for KP Protective Face Mask, submitted by Kp Trading Co., Ltd.. FDA's decision date was Dec 22, 2025, under product code FXX (Mask, Surgical).

Who makes the KP Protective Face Mask?

Kp Trading Co., Ltd., based in Hwaseong-Si, is the applicant of record for K243342.

How long did the K243342 review take?

FDA received the submission on Oct 25, 2024 and issued its decision on Dec 22, 2025, 423 days later.

← All decisions in December 2025