Pen-Inject 2.25
510(k) K954729
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK954729 | Date29 Jan 1996 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KZH
- FDA applicant
- Scandinavian Health , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.6920
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Pen-Inject 2.25 is a syringe needle introducer, classified under FDA regulation § 880.6920. It employs a spring-loaded mechanism to automatically drive a hypodermic needle into a patient’s skin to a predefined depth, ensuring consistent and controlled administration of injectable substances. This device is designed for use in general hospital settings, facilitating precise subcutaneous or intradermal injections without manual needle insertion.
This device is intended for single-use and is supplied sterile, adhering to Class II regulatory standards. It is not MRI-compatible and must be handled as a sharps device, with proper disposal following use. The Pen-Inject 2.25 is authorized under FDA 510(k) clearance (K954729) and is distributed under product code KZH. Storage should follow manufacturer guidelines to maintain sterility and functionality.
Other devices from Scandinavian Health Limited
Questions
AI-generated answers, 1 Oct 2026
What is the Pen-Inject 2.25 used for?
The Pen-Inject 2.25 is a syringe needle introducer designed to automate the insertion of a hypodermic needle into a patient’s skin for subcutaneous or intradermal injections. Its spring-loaded mechanism ensures consistent and controlled depth, reducing variability in manual needle insertion. This is particularly useful in general hospital settings where precise dosing and patient comfort are priorities.
How is the Pen-Inject 2.25 supplied and what are its sterility requirements?
The Pen-Inject 2.25 is supplied sterile and intended for single-use only, adhering to Class II regulatory standards. Sterility is maintained through manufacturing processes, and it must be handled as a sharps device to prevent contamination. Always follow manufacturer guidelines for storage to preserve sterility and functionality before use.
Is the Pen-Inject 2.25 reusable or designed for one-time use?
This device is explicitly designed for single-use only. After a single administration, it must be disposed of as a sharps waste to comply with safety and infection control protocols. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and patient safety.
What storage instructions should be followed for the Pen-Inject 2.25?
Storage instructions are provided by the manufacturer to maintain the device’s sterility and functionality. Typically, this involves keeping it in its original packaging, protected from moisture, extreme temperatures, and direct sunlight. Always refer to the included instructions or manufacturer documentation for specific storage conditions, as improper storage could affect performance or integrity.
Is the Pen-Inject 2.25 MRI-compatible?
No, the Pen-Inject 2.25 is explicitly stated as not MRI-compatible. This means it should not be used or stored in environments where MRI scans are performed, as exposure to magnetic fields could potentially damage the device or pose safety risks.