K240761 is an FDA 510(k) clearance for the Arisure® Closed Male Luer with Spike Adapter (YM060). This device is classified as a Set, I.v. Fluid Transfer (Class II - Special Controls, product code LHI).
Submitted by Yukon Medical, LLC (Durham, US). The FDA issued a Cleared decision on March 21, 2025, 366 days after receiving the submission on March 20, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K240761 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 2024 |
| Decision Date | March 21, 2025 |
| Days to Decision | 366 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LHI - Set, I.v. Fluid Transfer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |