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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 / May 2026 / K260051

510(k) cleared

CorVision® (91-205-Z0014)

CorVent® Medical, Inc. · May 12, 2026 · K260051

FDA cleared the CorVision® (91-205-Z0014) from CorVent® Medical, Inc. on May 12, 2026 under K260051, a traditional 510(k). The device falls under product code MOD, Accessory To Continuous Ventilator (Respirator), regulated at 21 CFR 868.5895 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Jan 8, 2026. The decision came 124 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 CorVent® Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260051?

K260051 is the FDA 510(k) for CorVision® (91-205-Z0014), submitted by CorVent® Medical, Inc.. FDA's decision date was May 12, 2026, under product code MOD (Accessory To Continuous Ventilator (Respirator)).

Who makes the CorVision® (91-205-Z0014)?

CorVent® Medical, Inc., based in Fargo, ND, is the applicant of record for K260051.

How long did the K260051 review take?

FDA received the submission on Jan 8, 2026 and issued its decision on May 12, 2026, 124 days later.

← All decisions in May 2026