K192382 is an FDA 510(k) clearance for the CapKlenZ. This device is classified as a Cap, Device Disinfectant (Class II - Special Controls, product code QBP).
Submitted by Star Mountain Medical, Inc. (El Paso, US). The FDA issued a Cleared decision on April 20, 2020, 234 days after receiving the submission on August 30, 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 | K192382 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 2019 |
| Decision Date | April 20, 2020 |
| Days to Decision | 234 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 |