WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

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 / May 2026 / K253816

510(k) cleared

MuCover (proposed name) Oral Wound Dressing

MoleculeX Co., Ltd. · May 21, 2026 · K253816

FDA cleared the MuCover (proposed name) Oral Wound Dressing from MoleculeX Co., Ltd. on May 21, 2026 under K253816, a traditional 510(k). The device falls under product code OLR, Oral Wound Dressing as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Nov 28, 2025. The decision came 174 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 MoleculeX Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253816?

K253816 is the FDA 510(k) for MuCover (proposed name) Oral Wound Dressing, submitted by MoleculeX Co., Ltd.. FDA's decision date was May 21, 2026, under product code OLR (Oral Wound Dressing).

Who makes the MuCover (proposed name) Oral Wound Dressing?

MoleculeX Co., Ltd., based in Hsinchu, is the applicant of record for K253816.

How long did the K253816 review take?

FDA received the submission on Nov 28, 2025 and issued its decision on May 21, 2026, 174 days later.

← All decisions in May 2026