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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 / July 2026 / K261728

510(k) cleared

One-Fil LC

Mediclus Co., Ltd. · Jul 21, 2026 · K261728

FDA cleared the One-Fil LC from Mediclus Co., Ltd. on Jul 21, 2026 under K261728, a traditional 510(k). The device falls under product code EJK, Liner, Cavity, Calcium Hydroxide, regulated at 21 CFR 872.3250 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on May 26, 2026. The decision came 56 days later, inside the 90 FDA-day goal for a 510(k).

Mediclus Co., Ltd. has 6 other decisions in the tracker over the last 12 months: K254201 (Any-Cem), K260485 (Any-Etch), K260819 (Any-Com Seal), K253797 (One-Stop).

Questions & Answers

What did FDA clear under K261728?

K261728 is the FDA 510(k) for One-Fil LC, submitted by Mediclus Co., Ltd.. FDA's decision date was Jul 21, 2026, under product code EJK (Liner, Cavity, Calcium Hydroxide).

Who makes the One-Fil LC?

Mediclus Co., Ltd., based in Cheongju-Si, is the applicant of record for K261728.

How long did the K261728 review take?

FDA received the submission on May 26, 2026 and issued its decision on Jul 21, 2026, 56 days later.

← All decisions in July 2026

Sources