Disposable Insulin Pen Needle
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K181069 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 Disposable Insulin Pen Needle is a sterile, pyrogen-free device composed of a sealing strip, needle hub, needle tube, small sheath, and large sheath. It is designed for subcutaneous injection of insulin when used in conjunction with an insulin pen.
The needle is sterilized by ethylene oxide and is supplied as a single-use device. It is available with FDA 510K clearance, MDD, and MDR authorizations, and is manufactured by Zhejiang Kindly Medical Devices Co., Ltd.
Frequently asked questions
What is the purpose of the Disposable Insulin Pen Needle?
The Disposable Insulin Pen Needle is designed for subcutaneous injection of insulin when used in conjunction with an insulin pen. It is composed of a sealing strip, needle hub, needle tube, small sheath, and large sheath.
Is the Disposable Insulin Pen Needle reusable?
No, the Disposable Insulin Pen Needle is supplied as a single-use device. It is sterilized by ethylene oxide and should not be reused for safety reasons.
What regulatory authorizations does the Disposable Insulin Pen Needle have?
The Disposable Insulin Pen Needle has FDA 510K clearance, MDD, and MDR authorizations. These indicate it meets regulatory requirements for safety and performance in various markets.
How is the Disposable Insulin Pen Needle supplied?
The Disposable Insulin Pen Needle is supplied as a sterile, pyrogen-free device. It comes with all necessary components including the sealing strip, needle hub, needle tube, small sheath, and large sheath.
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: Puncture Needles - Zhejiang Kindly Medical Devices Co.,Ltd., Zhejiang Kindly Medical Devices Co.,Ltd., Zhejiang Kindly Medical Devices Co., Ltd. - Made-in-China.com
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K181069 | Class II | Active |
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Manufacturer
- Manufacturer
- Zhejiang Kindly Medical Devices Co., Ltd.
Sources (2)
- FDA 510(k) K181069 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026