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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 / January 2026 / K253167

510(k) cleared

Any-Paste

Mediclus Co., Ltd. · Jan 12, 2026 · K253167

FDA cleared the Any-Paste from Mediclus Co., Ltd. on Jan 12, 2026 under K253167, a traditional 510(k). The device falls under product code KIF, Resin, Root Canal Filling, regulated at 21 CFR 872.3820 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Sep 26, 2025. The decision came 108 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 K253167?

K253167 is the FDA 510(k) for Any-Paste, submitted by Mediclus Co., Ltd.. FDA's decision date was Jan 12, 2026, under product code KIF (Resin, Root Canal Filling).

Who makes the Any-Paste?

Mediclus Co., Ltd., based in Cheongju-Si, is the applicant of record for K253167.

How long did the K253167 review take?

FDA received the submission on Sep 26, 2025 and issued its decision on Jan 12, 2026, 108 days later.

← All decisions in January 2026

Sources