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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 / June 2026 / K261541

510(k) cleared

VisionAir Enhanced Stock Stent

VisionAir Solutions · Jun 1, 2026 · K261541

FDA cleared the VisionAir Enhanced Stock Stent from VisionAir Solutions on Jun 1, 2026 under K261541, a special 510(k). The device falls under product code NWA, Prosthesis, Tracheal, Preformed/Molded, regulated at 21 CFR 878.3720 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on May 8, 2026. The decision came 24 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for VisionAir Solutions in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261541?

K261541 is the FDA 510(k) for VisionAir Enhanced Stock Stent, submitted by VisionAir Solutions. FDA's decision date was Jun 1, 2026, under product code NWA (Prosthesis, Tracheal, Preformed/Molded).

Who makes the VisionAir Enhanced Stock Stent?

VisionAir Solutions, based in Akron, OH, is the applicant of record for K261541.

How long did the K261541 review take?

FDA received the submission on May 8, 2026 and issued its decision on Jun 1, 2026, 24 days later.

← All decisions in June 2026