Submission Details
| 510(k) Number | K251592 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 23, 2025 |
| Decision Date | February 11, 2026 |
| Days to Decision | 264 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
SteriHub? Disinfecting Device and Protective Cover
Feb 2026
Decision
264d
Days
Class 2
Risk
About This 510(k) Submission
K251592 is an FDA 510(k) clearance for the SteriHub? Disinfecting Device and Protective Cover, a Cap, Device Disinfectant (Class II — Special Controls, product code QBP), submitted by 1World Vista Medical (Rio Verde, US). The FDA issued a Cleared decision on February 11, 2026, 264 days after receiving the submission on May 23, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.
Device Classification
| Product Code | QBP — Cap, Device Disinfectant |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5440 |
| Definition | Disinfect Needleless Access Valves And May Act As A Physical Barrier To Contamination If Not Removed For A Set Period Of Time |
Manufacturer
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