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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 / K260009

510(k) cleared

LungPoint Virtual Bronchoscopic Navigation (VBN) Software

Broncus Medical, Inc. · Apr 24, 2026 · K260009

FDA cleared the LungPoint Virtual Bronchoscopic Navigation (VBN) Software from Broncus Medical, Inc. on Apr 24, 2026 under K260009, a traditional 510(k). The device falls under product code LLZ, System, Image Processing, Radiological, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jan 2, 2026. The decision came 112 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 Broncus Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260009?

K260009 is the FDA 510(k) for LungPoint Virtual Bronchoscopic Navigation (VBN) Software, submitted by Broncus Medical, Inc.. FDA's decision date was Apr 24, 2026, under product code LLZ (System, Image Processing, Radiological).

Who makes the LungPoint Virtual Bronchoscopic Navigation (VBN) Software?

Broncus Medical, Inc., based in San Jose, CA, is the applicant of record for K260009.

How long did the K260009 review take?

FDA received the submission on Jan 2, 2026 and issued its decision on Apr 24, 2026, 112 days later.

← All decisions in April 2026