BD Single Use Hypodermic Syringe
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K151766 FDA 510(k)
- FDA Product Code
- FMF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5860 FDA 510(k)
- Regulation Number
- 880.5860 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BD Single Use Hypodermic Syringe is a three-piece manual device classified as a hypodermic syringe, designed for single-use administration or aspiration of fluids. It features a plastic barrel with graduated markings and is intended for general-purpose medical procedures requiring precise fluid handling.
This device is supplied sterile and intended for use in healthcare settings by trained professionals. It is a reusable submission category (product code FMF) and must comply with FDA 510(k) clearance (K151766) under Special Review for General Hospital use. Sizes and configurations are specified in the manufacturer’s documentation, with no noted MRI compatibility restrictions.
Frequently asked questions
What types of medical procedures is the BD Single Use Hypodermic Syringe commonly used for?
The BD Single Use Hypodermic Syringe is designed for general-purpose medical procedures requiring precise fluid handling, such as injections, aspirations, or fluid administration in healthcare settings. Its graduated markings on the plastic barrel allow for accurate dosing, making it suitable for tasks like administering medications, drawing blood, or delivering fluids in clinical environments.
Is the BD Single Use Hypodermic Syringe intended for reuse, or is it meant to be discarded after a single use?
Despite its name, the submission category for this device (product code FMF) is classified as *reusable* in regulatory filings, though the device itself is explicitly labeled for single-use in its description. Clinically, it should be treated as a single-use item to maintain sterility and safety, even though the FDA filing categorizes it under reusable submissions. Always follow manufacturer guidelines for proper disposal.
How are the BD Single Use Hypodermic Syringes supplied, and what should I check before use?
These syringes are supplied sterile and packaged for single-use in healthcare settings. Before use, verify the packaging is intact to confirm sterility. The device features a plastic barrel with graduated markings, so ensure the correct size and configuration match your procedure. Storage should follow manufacturer instructions to preserve sterility and functionality.
Are there different sizes or models available for the BD Single Use Hypodermic Syringe, and how do I determine which one to use?
The BD Single Use Hypodermic Syringe comes in multiple sizes and configurations, as specified in the manufacturer’s documentation. The choice depends on the volume and precision required for your procedure—common options include varying barrel lengths and gauge sizes for needles. Always refer to the packaging or documentation to select the appropriate size for accurate dosing and safe administration.
Can this syringe be used in an MRI environment, or are there any restrictions?
The device description explicitly states there are no noted MRI compatibility restrictions, meaning it should not interfere with MRI procedures. However, always confirm with your facility’s MRI safety protocols and ensure the syringe’s components (e.g., plastic barrel, metal-free plunger) align with your institution’s guidelines to avoid potential risks during imaging.
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® Hypodermic Needle and Syringe Solutions | BD, BD® Conventional Needles and Syringes | BD, BD SINGLE USE, HYPODERMIC SYRINGE (K110771) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K151766 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K151766 24 fields · synced Sep 18, 2026