K200299 is an FDA 510(k) clearance for the Curos Jet Disinfecting Cap. This device is classified as a Cap, Device Disinfectant (Class II - Special Controls, product code QBP).
Submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on October 29, 2020, 266 days after receiving the submission on February 6, 2020.
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 | K200299 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 06, 2020 |
| Decision Date | October 29, 2020 |
| Days to Decision | 266 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 |