Clickfine Pen Needle, Penfine Classic Pen Needle
FDA 510(k)Class II (US FDA 510(k))
by Ypsomed AG
Identifiers
- 510(k) Number
- K171984 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 Pen Needle and Penfine Classic Pen Needle are disposable, subcutaneous injection needles designed for use with insulin pen injectors. These devices feature a cannula intended to pierce the rubber injection port of the drug reservoir in pen injectors, enabling fluid delivery. The Clickfine variant incorporates a diamond-tip design with six bevels for enhanced precision, while the Penfine Classic maintains a standard cannula configuration. Both are intended for single-use applications in diabetes management.
These needles are supplied sterile and intended for subcutaneous injection of fluids such as insulin or exenatide. The Clickfine Pen Needle attaches via a screwing motion to compatible pen injectors, ensuring secure connection before use. They are classified under FDA product code FMI and were cleared via a Special 510(k) pathway in 2017. No additional regulatory markings or sterilization certifications are provided beyond the FDA clearance and manufacturer specifications.
Frequently asked questions
What is the primary difference between the Clickfine Pen Needle and the Penfine Classic Pen Needle in terms of design and functionality?
The Clickfine Pen Needle features a diamond-tip cannula with six bevels, which is designed to improve precision during subcutaneous injections. In contrast, the Penfine Classic Pen Needle uses a standard cannula configuration without the diamond-tip design. Both are intended for single-use with insulin pen injectors, but the Clickfine’s design may enhance accuracy when attaching to the injection port of the pen.
Are these needles reusable, or are they meant for single-use only?
These needles are explicitly designed for single-use only. The manufacturer emphasizes their disposable nature to ensure sterility and safety for subcutaneous injections, particularly in diabetes management where consistency and hygiene are critical.
How do I attach the Clickfine Pen Needle to an insulin pen injector, and is there a specific motion required?
The Clickfine Pen Needle is attached to compatible insulin pen injectors via a screwing motion, which ensures a secure connection before use. This design helps prevent accidental detachment during injection, reducing the risk of fluid leakage or incomplete dosing.
What types of fluids can these needles be used to inject, and are they approved for anything beyond insulin?
These needles are sterile and intended for subcutaneous injection of fluids such as insulin or exenatide, as specified by the manufacturer. While they are not explicitly labeled for other medications, their design aligns with common diabetes management protocols, and their FDA clearance under product code FMI (for insulin delivery systems) supports their use in that context.
How should these needles be stored, and is there any special handling required before first use?
Since these needles are sterile and disposable, they should be stored in a clean, dry place away from direct sunlight or extreme temperatures. The packaging should remain intact until use to maintain sterility. No additional preparation (like cleaning or priming) is required before injection, as they are pre-sterilized and ready for single-use.
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: Clickfine DiamondTip - my clickfine - distributoren.ypsomed.com, Clickfine Pen Needle, Penfine Classic Pen Needle (K171984) — FDA 510 (k ..., PDF 510k Special: Clickfine pen needle - Food and Drug Administration, Ypsomed AG FDA 510(k) General Hospital Products - Latest 2025
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K171984 | Class II | Active |
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Manufacturer
- Manufacturer
- Ypsomed AG
Sources (1)
- FDA 510(k) K171984 24 fields · synced Sep 20, 2026