K200425 is an FDA 510(k) clearance for the Female Luer Lock Cap. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Medsafety Solutions, LLC (Centennial, US). The FDA issued a Cleared decision on October 29, 2020, 252 days after receiving the submission on February 20, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K200425 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 20, 2020 |
| Decision Date | October 29, 2020 |
| Days to Decision | 252 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FPA - Set, Administration, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |