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BD SafeAssist

FDA 510(k)

Class II (US FDA 510(k))

510(k) K161553

by Becton, Dickinson and Company

Identifiers

510(k) Number
K161553 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 SafeAssist Pen Needle is a pen needle designed for use with pen injector devices. It is intended for the injection of drugs, including insulin and exenatide, and features an integrated safety shield that locks in place to reduce the risk of needle-stick injuries.

This device is supplied as a single-use, non-sterile product and is regulated under FDA 510(k) clearance (K161553) as a Special submission under the General Hospital advisory committee. It is manufactured by Becton, Dickinson and Company and is classified under product code FMI.

Frequently asked questions

What types of drugs can the BD SafeAssist Pen Needle be used for, and how does its safety feature work?

The BD SafeAssist Pen Needle is specifically designed for injecting drugs like insulin and exenatide through pen injector devices. Its key safety feature is an integrated safety shield that automatically locks into place after use, significantly reducing the risk of needle-stick injuries—a common concern with reusable or improperly disposed needles.

Is the BD SafeAssist Pen Needle meant for repeated use, and what does its sterility status mean for clinical settings?

The BD SafeAssist Pen Needle is explicitly labeled as a single-use device, meaning it should not be reused after one injection. It is also non-sterile, so it must be handled in accordance with clinical protocols to prevent contamination before use. Clinicians should follow standard aseptic techniques when preparing the device for injection.

How is the BD SafeAssist Pen Needle supplied, and what regulatory pathway does it follow?

The BD SafeAssist Pen Needle is supplied as a single-use, non-sterile product, packaged for individual administration. It was cleared by the FDA under a 510(k) submission (K161553), classified as *Substantially Equivalent* and reviewed by the General Hospital (HO) Advisory Committee as a *Special* submission. This means it was evaluated for compliance with existing standards for pen needles.

Are there different sizes or models of the BD SafeAssist Pen Needle, and if so, how would I identify them?

The provided data does not specify varying sizes or distinct models for the BD SafeAssist Pen Needle. Since it is designed for pen injectors and lacks additional size details in the summary, users should refer to the manufacturer’s labeling or packaging for specific gauge or length information, if applicable. Always confirm compatibility with your pen injector device.

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 SafeAssist by BECTON, DICKINSON AND COMPANY | FDA 510 (k) Summary, BD (company) - Wikipedia, BD SAFEASSIST - Becton, Dickinson and Company Trademark Registration, Contact Us - BD, BD Regulatory Documents: BD (Becton Dickinson and Company)

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) K161553 24 fields · synced Oct 6, 2026