SteriHub Disinfecting Device and Protective Cover— 510(k) K251592
Substantially Equivalent1World Vista Medical
FDA 510(k) clearance K251592 for SteriHub Disinfecting Device and Protective Cover, Substantially Equivalent on 2026-02-11. Applicant: 1World Vista Medical. Device class: 2.
Summary
1World Vista Medical's SteriHub Disinfecting Device and Protective Cover is filed under product code QBP, device disinfectant cap. The record doesn't describe the product beyond its name and that code name.
Class II, 21 CFR 880.5440. General Hospital is both the classification panel and the review panel, and it came in as a Traditional 510(k).
1World Vista Medical filed from Rio Verde, Arizona. The decision came 264 calendar days after FDA received it (May 23, 2025 to February 11, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- 1World Vista Medical
- Product code
- Product code QBP
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rio Verde, AZ, US
Recent devices under product code QBP
view allData sourced from openFDA. This site is unofficial and independent of the FDA.