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Clickfine AutoProtect Pen Needle

FDA 510(k)

Class II (US FDA 510(k))

510(k) K131123

by Ypsomed AG

Identifiers

510(k) Number
K131123 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 Clickfine AutoProtect Pen Needle is a device intended for the hypodermic injection of fluids into the body when attached to an injection pen. It features an integrated locking mechanism that automatically covers the needle with a safety shield after withdrawal from the body to minimize the risk of accidental needlestick injuries.

This device is supplied as a 5 mm pen needle and has received FDA 510k clearance. It is designed for use in a general hospital or clinical setting to facilitate safe medication delivery.

Frequently asked questions

What is the primary function of the Clickfine AutoProtect Pen Needle?

This device is intended for the hypodermic injection of fluids into the body when attached to a compatible injection pen. It is specifically designed for use in clinical or hospital settings to facilitate the safe delivery of medication.

How does the safety mechanism work on this needle?

The device features an integrated locking mechanism that automatically deploys a safety shield over the needle immediately after it is withdrawn from the body. This design is intended to minimize the risk of accidental needlestick injuries for healthcare providers.

What are the physical specifications of this pen needle?

The Clickfine AutoProtect Pen Needle is supplied as a 5 mm needle. It has been cleared through the FDA 510k process, identified by K-number K131123, for use in general hospital and clinical environments.

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 510k Special: Clickfine pen needle - Food and Drug Administration, Mylife Clickfine Auto Protect Pen Needles 5mm x 100, CLICKFINE AUTOPROTECT PEN NEEDLE (K110312) — FDA 510 (k) | Innolitics, mylife™ Clickfine® AutoProtect™ - MyLife - PDF Catalogs | Technical ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ypsomed AG

Sources (1)

  • FDA 510(k) K131123 24 fields · synced Sep 25, 2026