BD Vacutainer® One Use Holder
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K242320 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 One Use Holder 364815 is a single-use blood collection device designed to securely hold evacuated blood collection tubes during venipuncture procedures. It is part of the BD Vacutainer blood collection system and serves as a protective holder to reduce the risk of needle-stick injuries while maintaining specimen integrity.
This device is intended for use in clinical chemistry settings and is supplied as a single-use item to comply with OSHA safety guidelines. It is not reusable and must be discarded after one use to prevent contamination and injury. The holder is compatible with BD Vacutainer blood collection needles and sets, ensuring seamless integration into existing phlebotomy workflows. No regulatory status beyond the FDA 510(k) clearance is stated.
Frequently asked questions
What is the BD Vacutainer One Use Holder specifically designed to do during blood collection procedures?
The BD Vacutainer One Use Holder is designed to securely hold evacuated blood collection tubes while they are attached to a needle during venipuncture. Its primary purpose is to reduce the risk of needle-stick injuries to healthcare workers while ensuring the blood specimen remains protected and uncontaminated throughout the procedure.
Why is this device considered single-use, and what happens if it’s reused?
This device is classified as single-use to comply with OSHA safety guidelines and prevent contamination or injury. Reusing it could compromise sterility, increase the risk of bloodborne pathogen exposure, and violate occupational safety protocols, making it unsafe for repeated use.
How does the BD Vacutainer One Use Holder integrate with existing phlebotomy workflows?
It is specifically designed to work seamlessly with BD Vacutainer blood collection needles and sets, ensuring compatibility with standard phlebotomy equipment. This integration allows for a streamlined workflow without requiring additional training or modifications to existing procedures.
What regulatory pathway was followed for the FDA clearance of this device?
The BD Vacutainer One Use Holder received FDA clearance through a Traditional 510(k) process, determined to be Substantially Equivalent to a legally marketed predicate device. The review was conducted by the Clinical Chemistry (CH) Advisory Committee under product code JKA, with a decision date of November 1, 2024.
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® one-use holder | BD, BD Vacutainer® One-Use Holder - 364815 | BD, Becton Dickinson | BD Vacutainer One-use Holder (364815)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K242320 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K242320 24 fields · synced Sep 18, 2026