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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 / February 2026 / K253398

510(k) cleared

Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)

Efofex, Inc. · Feb 19, 2026 · K253398

FDA cleared the Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) from Efofex, Inc. on Feb 19, 2026 under K253398, a special 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 30, 2025. The decision came 142 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 Efofex, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253398?

K253398 is the FDA 510(k) for Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300), submitted by Efofex, Inc.. FDA's decision date was Feb 19, 2026, under product code FXX (Mask, Surgical).

Who makes the Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)?

Efofex, Inc., based in Rogers, AR, is the applicant of record for K253398.

How long did the K253398 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Feb 19, 2026, 142 days later.

← All decisions in February 2026