Arisure Closed Male Luer with Spike Adapter (YM060)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K240761 FDA 510(k)
- FDA Product Code
- LHI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5440 FDA 510(k)
- Regulation Number
- 880.5440 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Arisure Closed Male Luer with Spike Adapter (YM060) is a needle-free luer lock connector designed for closed-system drug transfer. It functions as a bi-directional valve to facilitate sterile connections between vial adapters, infusion bags, and administration sets, minimizing exposure to airborne contaminants and reducing the risk of contamination during medication preparation and administration.
This single-use, sterile device is intended for use within a closed-system transfer setup, pairing with complementary components like the Closed Vial Adapter and Dry Spike. Supplied in a non-pyrogenic, swabable configuration, it adheres to traditional 510(k) clearance standards under FDA regulatory oversight (K240761). The device is engineered for hospital environments, ensuring compatibility with standard infusion systems while maintaining sterility and safety throughout its intended use.
Frequently asked questions
What is the Arisure Closed Male Luer with Spike Adapter (YM060) used for?
The Arisure Closed Male Luer with Spike Adapter (YM060) is designed for closed-system drug transfer, allowing sterile connections between vial adapters, infusion bags, and administration sets. It acts as a bi-directional valve to minimize exposure to airborne contaminants and reduce contamination risks during medication preparation and administration in hospital settings.
How is the Arisure Closed Male Luer with Spike Adapter (YM060) supplied?
This device is supplied in a single-use, sterile configuration. It is packaged in a non-pyrogenic, swabable format, ensuring compatibility with standard hospital infusion systems while maintaining sterility throughout its intended use.
Is the Arisure Closed Male Luer with Spike Adapter (YM060) reusable?
No, the Arisure Closed Male Luer with Spike Adapter (YM060) is intended for single-use only. Its design and sterility specifications are optimized for one-time use in closed-system drug transfer to prevent contamination and ensure patient safety.
What complementary components pair with the Arisure Closed Male Luer with Spike Adapter (YM060)?
The Arisure Closed Male Luer with Spike Adapter (YM060) is engineered to pair with complementary components like the Closed Vial Adapter and Dry Spike, forming a complete closed-system transfer setup for medication preparation and administration.
How is the sterility of the Arisure Closed Male Luer with Spike Adapter (YM060) maintained?
The device is supplied in a sterile, non-pyrogenic packaging that allows for swabable surfaces, ensuring sterility is preserved until use. Its closed-system design further minimizes contamination risks during medication handling in clinical environments.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Arisure® Closed Male Luer | Needle-Free Luer Lock Connection, Arisure® Closed System Transfer Device | Yukon Medical, Arisure® Closed Male Luer with Spike Adapter (YM060) (K240761) — FDA ..., PDF Arisure® Closed Male Luer with Spike Adapter
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K240761 | Class II | Active |
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Manufacturer
- Manufacturer
- Yukon Medical, LLC
Sources (1)
- FDA 510(k) K240761 24 fields · synced Oct 6, 2026