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BD Pen Needle

FDA 510(k)

Class II (US FDA 510(k))

510(k) K162516

by Becton, Dickinson and Company

Identifiers

510(k) Number
K162516 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 to interface with insulin pens, facilitating precise subcutaneous administration of insulin in diabetes management.

This device is supplied as a single-use, sterile, disposable component intended for use with insulin pens in clinical and home healthcare settings. It is regulated under the FDA’s 510(k) clearance (K162516) and falls under the General Hospital advisory committee classification. No additional sterility or MRI safety information is provided in the specifications.

Frequently asked questions

What is the BD Pen Needle specifically designed for and in what settings can it be used?

The BD Pen Needle is designed exclusively for insulin delivery systems, allowing precise subcutaneous insulin administration in diabetes management. It is intended for use with insulin pens in both clinical settings, such as hospitals or doctor’s offices, and home healthcare environments where patients self-administer insulin.

Is the BD Pen Needle meant for single-use or can it be reused?

The BD Pen Needle is explicitly labeled as a single-use, disposable component. This design ensures sterility and safety for each administration, preventing cross-contamination or potential infection risks associated with reuse.

How is the BD Pen Needle supplied, and what does that mean for handling?

The BD Pen Needle is supplied as a sterile, disposable item, meaning it comes pre-packaged and ready for immediate use without additional sterilization. This ensures reliability and reduces the risk of contamination during handling, as it is not intended for reprocessing or reuse.

What regulatory pathway does the BD Pen Needle follow, and how does that affect its use?

The BD Pen Needle follows the FDA’s 510(k) clearance process, specifically under clearance number K162516, and is classified as substantially equivalent to existing devices. This means it has undergone FDA review to confirm its safety and effectiveness for its intended use with insulin pens, ensuring compliance with U.S. medical device regulations.

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, Becton Dickinson – Wikipedia, BD (Becton Dickinson) Is Now Embecta - Same Products under a New Name, BD (company) - 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) K162516 24 fields · synced Sep 20, 2026