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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 / March 2026 / K254040

510(k) cleared

LungFlow Basket Catheter

Free Flow Medical, Inc. · Mar 12, 2026 · K254040

FDA cleared the LungFlow Basket Catheter from Free Flow Medical, Inc. on Mar 12, 2026 under K254040, 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 Dec 16, 2025. The decision came 86 days later, inside the 90 FDA-day goal for a 510(k).

Free Flow Medical, Inc. has one other decision in the tracker over the last 12 months: K254037 (LungFlow Airway Catheter).

Questions & Answers

What did FDA clear under K254040?

K254040 is the FDA 510(k) for LungFlow Basket Catheter, submitted by Free Flow Medical, Inc.. FDA's decision date was Mar 12, 2026, under product code KTI (Bronchoscope Accessory).

Who makes the LungFlow Basket Catheter?

Free Flow Medical, Inc., based in Fremont, CA, is the applicant of record for K254040.

How long did the K254040 review take?

FDA received the submission on Dec 16, 2025 and issued its decision on Mar 12, 2026, 86 days later.

← All decisions in March 2026

Sources