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Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K202319

by Tianjin Huahong Technology Co., Ltd.

Identifiers

510(k) Number
K202319 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)

This device is a needle for insulin pens, designed for subcutaneous insulin delivery. It includes both ordinary and safety-type variants, each engineered for compatibility with pen injector systems to facilitate precise insulin administration in diabetes management.

The needles are supplied sterile and intended for single-use. They are classified under product code FMI and comply with regulatory standards, including FDA 510(k) clearance and MDR authorisation. Both ordinary and safety types are manufactured by Tianjin Huahong Technology Co., Ltd., with the safety type incorporating protective features to enhance user safety.

Frequently asked questions

What is the primary purpose of these insulin pen needles, and how do the ordinary and safety types differ in function?

These needles are designed specifically for subcutaneous insulin delivery using insulin pen injector systems, helping patients with diabetes administer precise doses. The ordinary type is a standard needle for basic insulin delivery, while the safety type includes protective features—such as a guard or sheath—to reduce the risk of needle-stick injuries after use, enhancing user safety during disposal.

Are these needles reusable, or are they meant for single-use only? How does this affect their sterility?

These needles are intended for single-use only, as explicitly stated in the device description. They are supplied sterile to ensure safe, contamination-free administration during each use, which is critical for diabetes management to prevent infections or complications.

What regulatory pathways have these insulin pen needles followed, and how does that impact their availability?

The needles have undergone FDA 510(k) clearance (traditional pathway, classified as substantially equivalent) and MDR authorization, confirming compliance with U.S. and EU regulatory standards. This means they meet established safety and performance requirements for insulin delivery devices, ensuring they can be legally marketed and used in both regulated markets.

Are there different sizes or models available, or is this a one-size-fits-all solution for insulin pens?

The provided data does not specify varying sizes or models beyond the distinction between ordinary and safety types. Both variants are designed for compatibility with insulin pen systems, but exact gauge lengths or other dimensions would require additional product documentation from the manufacturer, Tianjin Huahong Technology Co., Ltd.

How should these needles be stored to maintain their sterility and usability before first use?

While the data doesn’t detail specific storage instructions, standard practice for sterile single-use medical devices—like insulin pen needles—recommends storing them in a cool, dry place, protected from direct sunlight or extreme temperatures. The packaging should remain intact until use to preserve sterility, as contamination could compromise insulin delivery safety.

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: Needle for Insulin Pen | China Manufacturer | Tianjin HUAHONG, Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) by ..., Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Tianjin Huahong Technology Co., Ltd.

Sources (2)

  • FDA 510(k) K202319 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026