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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 / K253797

510(k) cleared

One-Stop

Mediclus Co., Ltd. · Feb 27, 2026 · K253797

FDA cleared the One-Stop from Mediclus Co., Ltd. on Feb 27, 2026 under K253797, a traditional 510(k). The device falls under product code MVL, Cord, Retraction as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Nov 28, 2025. The decision came 91 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Mediclus Co., Ltd. has 6 other decisions in the tracker over the last 12 months: K254201 (Any-Cem), K261728 (One-Fil LC), K260485 (Any-Etch), K260819 (Any-Com Seal).

Questions & Answers

What did FDA clear under K253797?

K253797 is the FDA 510(k) for One-Stop, submitted by Mediclus Co., Ltd.. FDA's decision date was Feb 27, 2026, under product code MVL (Cord, Retraction).

Who makes the One-Stop?

Mediclus Co., Ltd., based in Cheongju-Si, is the applicant of record for K253797.

How long did the K253797 review take?

FDA received the submission on Nov 28, 2025 and issued its decision on Feb 27, 2026, 91 days later.

← All decisions in February 2026

Sources