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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 / July 2026 / K254037

510(k) cleared

LungFlow Airway Catheter

Free Flow Medical, Inc. · Jul 10, 2026 · K254037

FDA cleared the LungFlow Airway Catheter from Free Flow Medical, Inc. on Jul 10, 2026 under K254037, a traditional 510(k). The device falls under product code EOQ, Bronchoscope (Flexible Or Rigid), 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 206 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Free Flow Medical, Inc. has one other decision in the tracker over the last 12 months: K254040 (LungFlow Basket Catheter).

Questions & Answers

What did FDA clear under K254037?

K254037 is the FDA 510(k) for LungFlow Airway Catheter, submitted by Free Flow Medical, Inc.. FDA's decision date was Jul 10, 2026, under product code EOQ (Bronchoscope (Flexible Or Rigid)).

Who makes the LungFlow Airway Catheter?

Free Flow Medical, Inc., based in Fremont, CA, is the applicant of record for K254037.

How long did the K254037 review take?

FDA received the submission on Dec 16, 2025 and issued its decision on Jul 10, 2026, 206 days later.

← All decisions in July 2026

Sources