Dana Diabecare Ii Insulin Pump & Superline-Easyrelease, Soft-Release-St, & Soft…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K022317 FDA 510(k)
- FDA Product Code
- LZG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5725 FDA 510(k)
- Regulation Number
- 880.5725 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Dana Diabecare II Insulin Pump is a Class II medical device designed for continuous subcutaneous insulin infusion in diabetic patients. It delivers precise, programmable insulin doses to manage blood glucose levels, featuring integrated tubing and infusion sets for reliable administration. The Superline EasyRelease, Soft-Release-ST, and Soft-Release-R infusion sets are compatible attachments, providing secure and flexible insertion for prolonged wear.
This device is intended for single-use and requires no sterilization. It operates in outpatient and hospital settings, including general medical facilities, and is compatible with MRI environments under specified conditions. The infusion sets are supplied sterile and packaged individually, with the pump requiring no special storage beyond its original packaging. Authorized under FDA 510(k) clearance, MDD, and MDR, it adheres to regulatory standards for insulin infusion systems.
Frequently asked questions
What is the purpose of the Dana Diabecare II Insulin Pump?
The Dana Diabecare II Insulin Pump is designed for continuous subcutaneous insulin infusion in diabetic patients to deliver precise, programmable insulin doses for managing blood glucose levels.
Are the infusion sets included with the pump single-use or reusable?
The Superline EasyRelease, Soft-Release-ST, and Soft-Release-R infusion sets are intended for single-use and require no sterilization.
How are the infusion sets supplied and what is their sterility status?
The infusion sets are supplied sterile and packaged individually, ensuring they are ready for immediate use without additional preparation.
What are the compatible environments for using this insulin pump system?
The device operates in outpatient and hospital settings, including general medical facilities, and is compatible with MRI environments under specified conditions.
What regulatory approvals does the Dana Diabecare II Insulin Pump have?
The device is authorized under FDA 510(k) clearance, MDD, and MDR, adhering to regulatory standards for insulin infusion systems.
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
MDR
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K022317 | Class II | Active |
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Manufacturer
- Manufacturer
- Sooil Development Co., Ltd.
Sources (2)
- FDA 510(k) K022317 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026