K251592 is an FDA 510(k) clearance for the SteriHub™ Disinfecting Device and Protective Cover. This device is classified as 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 FDA review panel. Regulated under 21 CFR 880.5440. Disinfect Needleless Access Valves And May Act As A Physical Barrier To Contamination If Not Removed For A Set Period Of Time.
| 510(k) Number | K251592 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| 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 |