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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 / February 2026 / K251592

510(k) cleared

SteriHub Disinfecting Device and Protective Cover

1World Vista Medical · Feb 11, 2026 · K251592

FDA cleared the SteriHub Disinfecting Device and Protective Cover from 1World Vista Medical on Feb 11, 2026 under K251592, a traditional 510(k). The device falls under product code QBP, Cap, Device Disinfectant, regulated at 21 CFR 880.5440 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on May 23, 2025. The decision came 264 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 1World Vista Medical in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251592?

K251592 is the FDA 510(k) for SteriHub Disinfecting Device and Protective Cover, submitted by 1World Vista Medical. FDA's decision date was Feb 11, 2026, under product code QBP (Cap, Device Disinfectant).

Who makes the SteriHub Disinfecting Device and Protective Cover?

1World Vista Medical, based in Rio Verde, AZ, is the applicant of record for K251592.

How long did the K251592 review take?

FDA received the submission on May 23, 2025 and issued its decision on Feb 11, 2026, 264 days later.

← All decisions in February 2026