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Droplet Pen Needle

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K171982

by Htl Strefa S A

Identifiers

510(k) Number
K171982 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 Droplet Pen Needle is a sterile, single-use medical device classified as a pen needle (FMI product code), designed for subcutaneous injection via pen injector devices. It is engineered for compatibility with insulin pens and similar systems, facilitating precise drug delivery by healthcare professionals or lay users.

Supplied sterile and intended for one-time use, these needles are manufactured from surgical steel and are compatible with most Type A pen injector devices. Authorised under FDA 510K (K171982), MDD, and MDR, they are regulated as a Class II medical device. Storage and handling must adhere to sterile medical device protocols to ensure integrity before use.

Frequently asked questions

What types of pen injector devices is the Droplet Pen Needle compatible with, and why is this important for users?

The Droplet Pen Needle is designed for compatibility with most Type A pen injector devices, which are commonly used for insulin delivery. This compatibility ensures that healthcare professionals or lay users can attach it securely to their existing insulin pens or similar systems without modification, enabling precise subcutaneous injections. The focus on Type A devices helps standardize usage across different brands while maintaining ease of use for patients managing chronic conditions like diabetes.

How should the Droplet Pen Needle be stored, and why does this matter for its performance?

The Droplet Pen Needle must be stored following sterile medical device protocols to preserve its integrity before use. Since it is supplied sterile and intended for single-use only, improper storage—such as exposure to moisture, heat, or contamination—could compromise its sterility or structural integrity. Adhering to these guidelines ensures the needle remains safe and effective for its intended application when first opened.

Is the Droplet Pen Needle reusable, and if not, what materials are used to ensure safety and precision?

No, the Droplet Pen Needle is not reusable—it is explicitly designed for one-time use to maintain hygiene and safety standards. It is manufactured from surgical steel, a material chosen for its durability, precision, and resistance to corrosion or deformation during use. This construction supports accurate drug delivery while minimizing risks associated with repeated use.

What regulatory pathways does the Droplet Pen Needle follow, and how does this affect its availability?

The Droplet Pen Needle is authorized through multiple regulatory routes, including FDA 510K clearance (K171982), MDD (Medical Device Directive), and MDR (Medical Device Regulation). These pathways confirm its compliance with safety and performance standards in the U.S., EU, and other markets where applicable. For buyers or clinicians, this means the device meets stringent requirements for Class II medical devices, ensuring reliability and traceability in clinical or home-use settings.

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: Droplet pen needles - High Tech Lab - htl-strefa.com, PDF STERILE, SINGLE-USE PEN NEEDLES - htl-strefa.com, HTL-Strefa Droplet Pen Needles - discreetdiabetessupplies.com, HTL-Strefa Droplet Pen Needles - mediboxus.com

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Htl Strefa S A
FDA Applicant
Htl-Strefa S.A

Sources (2)

  • FDA 510(k) K171982 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026