BD Vacutainer Luer-Lok Access Device, BD Vacutainer Blood Transfer Device
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K222478 FDA 510(k)
- FDA Product Code
- JKA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1675 FDA 510(k)
- Regulation Number
- 862.1675 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BD Vacutainer Luer-Lok Access Device and Blood Transfer Device are sterile, single-use medical devices designed for secure blood specimen sampling and transfer. The Luer-Lok connection ensures a tight seal between the access device and blood collection tubes, preventing leakage and contamination while maintaining sterility. These devices are intended for use in clinical chemistry applications, facilitating reliable sample collection for laboratory analysis.
These devices are supplied sterile and intended for single-use only, adhering to standard blood collection and transfer protocols in clinical settings. The Luer-Lok Access Device (reference code 36490200) is compatible with standard blood collection tubes and provides a secure connection to minimize leakage. The product is authorized under FDA 510(k) clearance (K222478) and classified under product code JKA, with no third-party review involved. Storage should follow manufacturer guidelines to maintain sterility and functionality.
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: BD Vacutainer® Luer-Lok™ Access Device - 36490200 | BD, Luer-Lok Access Device BD Becton Dickinson 364902 - Vitality Medical, BD (company) - Wikipedia, BD Vacutainer Luer-Lock Access Device | Safe Blood Collection
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222478 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K222478 24 fields · synced Sep 18, 2026