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BD Nano 2nd Gen Pen Needle

FDA 510(k)

Class II (US FDA 510(k))

510(k) K213156

by Becton, Dickinson and Company

Identifiers

510(k) Number
K213156 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 Nano 2nd Gen Pen Needle is a single-use, sterile, disposable hypodermic needle assembly designed for subcutaneous drug delivery. It is categorized as a pen needle, consisting of a needle, hub, inner shield, and wide outer cover, intended for use with pen injector devices. This device is engineered to minimize injection pain and reduce the risk associated with reuse, adhering to medical best practices for patient safety.

This needle is supplied sterile and intended for one-time use only, ensuring patient safety and infection control. It is compatible with pen injectors and is operated manually by patients or clinicians in both home and clinical settings. The device is regulated under FDA 510(k) clearance (K213156) and is classified under product code FMI. Storage and handling must comply with sterile medical device protocols to maintain integrity.

Frequently asked questions

What makes the BD Nano 2nd Gen Pen Needle different from other pen needles in terms of patient comfort and safety?

The BD Nano 2nd Gen Pen Needle is specifically designed to minimize injection pain, which is a key concern for patients using subcutaneous drug delivery systems. Its engineering focuses on reducing discomfort during use while also preventing reuse—a critical safety measure to lower infection risks. This aligns with medical best practices for patient safety, ensuring a smoother and safer experience compared to reusable or poorly designed needles.

Is this needle compatible with all pen injector devices, or are there specific models it works with?

The BD Nano 2nd Gen Pen Needle is designed for use with pen injector devices in general, but compatibility should be confirmed with the specific model you plan to use. While it is engineered to fit standard pen injectors, manufacturers may vary in design, so always check the manufacturer’s guidelines to ensure proper fit and function before use.

How should I store the BD Nano 2nd Gen Pen Needle to maintain its sterility and usability?

Since the BD Nano 2nd Gen Pen Needle is sterile and intended for single-use, it must be stored according to sterile medical device protocols. Keep it in its original packaging until ready for use, away from direct sunlight, moisture, and extreme temperatures. Proper storage ensures the needle remains uncontaminated and functional for its intended application.

Can this needle be reused, and why is single-use recommended?

No, the BD Nano 2nd Gen Pen Needle is explicitly designed for one-time use only. Reuse is strongly discouraged because it increases the risk of infection, contamination, and potential damage to the needle, which could compromise patient safety. The device’s design adheres to medical best practices by eliminating reuse risks, ensuring a safer and more hygienic injection process.

What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its safety and reliability?

The BD Nano 2nd Gen Pen Needle received FDA clearance through a 510(k) pathway (K213156), which means it was determined to be substantially equivalent to a legally marketed predicate device. This process ensures that the device meets FDA safety and performance standards before approval. The clearance also indicates that it was reviewed under the General Hospital (HO) advisory committee, reinforcing its compliance with regulatory requirements for patient safety and efficacy.

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: PDF BD Nano 2nd Gen As part of your injection routine,, BD Nano 2nd Gen Pen Needle (K212015) — FDA 510(k) | Innolitics, BD (company) - Wikipedia, PDF BD Nano 2G Clinical Detail Aid_20-063.indd

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) K213156 24 fields · synced Sep 18, 2026