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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 / December 2025 / K251402

510(k) cleared

LIA-1 Catheter (542-1)

Leadoptik, Inc. · Dec 19, 2025 · K251402

FDA cleared the LIA-1 Catheter (542-1) from Leadoptik, Inc. on Dec 19, 2025 under K251402, 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 6, 2025. The decision came 227 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Leadoptik, Inc. has one other decision in the tracker over the last 12 months: K251730 (LIA Console (542-7)).

Questions & Answers

What did FDA clear under K251402?

K251402 is the FDA 510(k) for LIA-1 Catheter (542-1), submitted by Leadoptik, Inc.. FDA's decision date was Dec 19, 2025, under product code KTI (Bronchoscope Accessory).

Who makes the LIA-1 Catheter (542-1)?

Leadoptik, Inc., based in San Jose, CA, is the applicant of record for K251402.

How long did the K251402 review take?

FDA received the submission on May 6, 2025 and issued its decision on Dec 19, 2025, 227 days later.

← All decisions in December 2025

Sources