K193190 is an FDA 510(k) clearance for the BD PureHub Disinfecting Cap. This device is classified as a Cap, Device Disinfectant (Class II - Special Controls, product code QBP).
Submitted by Becton, Dickinson and Company (Franklin Lakes, US). The FDA issued a Cleared decision on November 9, 2020, 356 days after receiving the submission on November 19, 2019.
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 | K193190 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 19, 2019 |
| Decision Date | November 09, 2020 |
| Days to Decision | 356 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 |