K190918 is an FDA 510(k) clearance for the SwabTip Male Disinfectant Cap. This device is classified as a Cap, Device Disinfectant (Class II - Special Controls, product code QBP).
Submitted by Icu Medical (Lake Forest, US). The FDA issued a Cleared decision on March 6, 2020, 332 days after receiving the submission on April 9, 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 | K190918 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 09, 2019 |
| Decision Date | March 06, 2020 |
| Days to Decision | 332 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 |