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Easydrip Classic Pen Needle +3 more models

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K252908

by Sandstone Medical (suzhou) Inc.

Identifiers

510(k) Number
K252908 FDA 510(k)
FDA Product Code
FMI FDA 510(k)
Models / Variants
Easydrip Classic Pen Needle FDA 510(k)EUDAMED
Easydrip Plus Pen Needle FDA 510(k)EUDAMED
Easydrip Classic Pro Pen Needle FDA 510(k)EUDAMED
Easydrip Plus Pro Pen Needle FDA 510(k)EUDAMED

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 Easydrip Pen Needles are insulin delivery devices designed for subcutaneous injection, classified under the nomenclature code FMI (Insulin Delivery Needles). These single-use, disposable needles are engineered to attach to insulin pen devices, facilitating precise and consistent insulin administration for diabetes management.

Supplied sterile and intended for single-use, these needles are regulated under FDA 510(k) clearance (K252908) and EU MDR compliance. They are manufactured by Sandstone Medical (Suzhou) Inc. and distributed in sterile packaging for immediate clinical use. No MRI safety information or reusable variants are specified.

Frequently asked questions

What types of insulin pen devices are the Easydrip Pen Needles designed to attach to, and how do they differ between the Classic, Plus, and Pro models?

The Easydrip Pen Needles are engineered specifically for subcutaneous insulin delivery via insulin pen devices, but the exact compatibility with pen brands or models isn’t detailed in the data. The ‘Classic,’ ‘Plus,’ and ‘Pro’ designations likely refer to variations in needle length, gauge, or attachment mechanism (e.g., clicker or twist-on systems) to optimize precision and user experience. However, the data does not specify these differences—only that all are single-use, sterile, and classified under the same FDA 510(k) clearance (K252908) for insulin delivery needles.

Are the Easydrip Pen Needles reusable, and if not, how should they be disposed of after single use?

The Easydrip Pen Needles are explicitly designed for single-use only, as stated in the description. Since they are sterile and disposable, they must be discarded immediately after use to prevent contamination or reuse risks. The data does not provide disposal guidelines, but standard medical practice for insulin pen needles includes safe disposal in a sharps container to avoid needle-stick injuries.

What packaging and sterility assurances come with the Easydrip Pen Needles, and how should they be stored before use?

The needles are supplied in sterile packaging, intended for immediate clinical use without additional preparation. Storage instructions aren’t specified, but sterile medical devices like these are typically stored in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging should remain intact until use to maintain sterility.

How do I verify the regulatory compliance of these needles, particularly for FDA and EU markets?

The Easydrip Pen Needles hold FDA 510(k) clearance (K252908) and comply with EU MDR (Medical Device Regulation). For FDA compliance, you can verify the clearance status via the FDA’s [510(k) Database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm) using the clearance number. For EU MDR compliance, check the manufacturer’s documentation or the device’s labeling for the MDR CE marking and UDI (Unique Device Identifier). The data does not provide UDI details, but the MDR compliance is confirmed in the authorization section.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Sandstone Medical (suzhou) Inc.
FDA Applicant
Sandstone Medical (Suzhou), Inc.

Sources (2)

  • FDA 510(k) K252908 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026