Arisure Closed System Drug Transfer Device (CSTD)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K201422 FDA 510(k)
- FDA Product Code
- ONB 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)
A Closed System Drug Transfer Device (CSTD) is a device designed to mechanically prohibit the release of hazardous drugs in vapor, aerosol, or liquid form during preparation and administration, and to prevent the introduction of microbial and airborne contaminants. The Arisure Closed System Drug Transfer Device (CSTD) is a needleless, membrane-to-membrane closed system transfer device platform built for the preparation and administration of hazardous injectable medications, designed around familiar luer-lock connections to support safety, consistency, and ease of use.
The device is supplied as a reusable system intended for use in general hospital settings. It is authorized under FDA 510(k) clearance (K201422) and classified as a Class II medical device under regulation number 880.5440. The device is not described as sterile, single-use, or MRI-safe in the provided data, and no storage conditions are specified.
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 System Transfer Device | Yukon Medical, Yukon Medical | Closed System Transfer & Vial Access Devices, Arisure Closed System Drug Transfer Device (CSTD) (K201422) — FDA 510 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201422 | Class II | Active |
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Manufacturer
- Manufacturer
- Yukon Medical, LLC
Sources (1)
- FDA 510(k) K201422 24 fields · synced Sep 21, 2026