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BD Pen Needle

FDA 510(k)

Class II (US FDA 510(k))

510(k) K213478

by Becton, Dickinson and Company

Identifiers

510(k) Number
K213478 FDA 510(k)
FDA Product Code
FMI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5570 FDA 510(k)
Regulation Number
880.5570 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The BD Pen Needle is a pen needle designed for insulin delivery systems, classified under the hypodermic needle category. It is engineered for compatibility with insulin pens, facilitating precise subcutaneous administration of insulin. Constructed for single-use, it ensures sterility and reduces the risk of contamination or cross-infection. Its design prioritises ease of use and minimal patient discomfort during injection.

This device is supplied sterile and intended for single-use only, adhering to standard infection control protocols. It is authorised under FDA 510K clearance (K213478) and falls under the FMI product code, categorised within the General Hospital advisory committee review. Storage requires protection from moisture and extreme temperatures, as specified in manufacturer guidelines. No additional regulatory markings beyond the stated FDA clearance are provided in the data.

Frequently asked questions

What types of insulin delivery systems is the BD Pen Needle compatible with, and how does its design reduce patient discomfort during use?

The BD Pen Needle is specifically designed for compatibility with insulin pens, ensuring seamless integration for subcutaneous insulin administration. Its engineering focuses on precision and smooth insertion to minimize patient discomfort, which is a key feature for users requiring frequent injections. The needle’s design prioritizes ease of use while maintaining accuracy in dosing.

Is the BD Pen Needle reusable, and if not, what measures are in place to ensure patient safety with single-use?

The BD Pen Needle is intended for single-use only, which aligns with infection control protocols to prevent contamination or cross-infection. It is supplied sterile, ensuring each use begins with a clean, sterile surface. This design eliminates risks associated with reuse, such as needle damage or microbial buildup, which could compromise patient safety.

What storage conditions are required for the BD Pen Needle to maintain its integrity and sterility?

The BD Pen Needle must be stored in a way that protects it from moisture and extreme temperatures, as outlined in the manufacturer’s guidelines. Proper storage ensures the needle remains sterile and functional until use. Avoiding environmental stressors helps preserve its performance and safety for single-use applications.

How do I identify the regulatory clearance status of the BD Pen Needle, and what does this mean for its use in clinical settings?

The BD Pen Needle holds FDA 510(k) clearance (K213478), which means it has been determined to be substantially equivalent to a legally marketed predicate device. This clearance confirms it meets regulatory standards for safety and effectiveness as an insulin delivery needle. Clinicians can rely on this status as part of their due diligence when selecting devices for insulin administration.

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® Conventional Needles and Syringes | BD, BD (Becton Dickinson) Is Now Embecta - Same Products under a New Name, BD (company) - Wikipedia, Becton Dickinson – Wikipedia

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Becton, Dickinson and Company

Sources (1)

  • FDA 510(k) K213478 24 fields · synced Sep 20, 2026