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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 / January 2026 / K252650

510(k) cleared

Disposable Medical Face Mask

Makrite Industries, Inc. · Jan 5, 2026 · K252650

FDA cleared the Disposable Medical Face Mask from Makrite Industries, Inc. on Jan 5, 2026 under K252650, 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 22, 2025. The decision came 136 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 Makrite Industries, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252650?

K252650 is the FDA 510(k) for Disposable Medical Face Mask, submitted by Makrite Industries, Inc.. FDA's decision date was Jan 5, 2026, under product code FXX (Mask, Surgical).

Who makes the Disposable Medical Face Mask?

Makrite Industries, Inc., based in New Taipei, is the applicant of record for K252650.

How long did the K252650 review take?

FDA received the submission on Aug 22, 2025 and issued its decision on Jan 5, 2026, 136 days later.

← All decisions in January 2026