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BD Nano 2nd Gen Pen Needle

FDA 510(k)

Class II (US FDA 510(k))

510(k) K212015

by Becton, Dickinson and Company

Identifiers

510(k) Number
K212015 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 injection. It is intended for use with pen injector devices to deliver medications, featuring a needle, hub, inner shield, and wide outer cover. This device is classified as a needle assembly under the nomenclature authority’s definitions, specifically tailored for manual patient or clinician use in both home and clinical settings.

This pen needle is supplied sterile and intended for single-use only, as reuse is associated with increased injection pain and risk. It is compatible with pen injectors for subcutaneous drug delivery and adheres to FDA 510(k) clearance (K212015) under the Traditional pathway. Storage and handling follow standard sterile medical device protocols, with no additional regulatory restrictions noted beyond its single-use designation.

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) K212015 24 fields · synced Sep 18, 2026