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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 / April 2026 / K251478

510(k) cleared

ClearTip TBNA Type

Finemedix Co., Ltd. · Apr 16, 2026 · K251478

FDA cleared the ClearTip TBNA Type from Finemedix Co., Ltd. on Apr 16, 2026 under K251478, a traditional 510(k). The device falls under product code KTI, Bronchoscope Accessory, regulated at 21 CFR 874.4680 as a Class 2 device. The review panel was Ear, Nose, Throat.

FDA logged the submission as received on May 13, 2025. The decision came 338 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 Finemedix Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251478?

K251478 is the FDA 510(k) for ClearTip TBNA Type, submitted by Finemedix Co., Ltd.. FDA's decision date was Apr 16, 2026, under product code KTI (Bronchoscope Accessory).

Who makes the ClearTip TBNA Type?

Finemedix Co., Ltd., based in Daegu, is the applicant of record for K251478.

How long did the K251478 review take?

FDA received the submission on May 13, 2025 and issued its decision on Apr 16, 2026, 338 days later.

← All decisions in April 2026