Sub-Q Subcutaneous Tissue Infusion Set
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K140131 FDA 510(k)
- FDA Product Code
- FPA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5440 FDA 510(k)
- Regulation Number
- 880.5440 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Sub-Q Subcutaneous Tissue Infusion Set is a medical device classified as a subcutaneous infusion set (Product Code: FPA) designed for the administration of fluids or medications directly into the subcutaneous tissue. It facilitates continuous or intermittent infusion by providing a secure, low-pressure connection between a reservoir or pump and the patient’s tissue, reducing the risk of leakage or dislodgement during use.
This device is intended for single-use only and is supplied sterile, ensuring compatibility with subcutaneous infusion protocols in clinical and home-care settings. It is intended for use with compatible infusion pumps or reservoirs and must be handled with sterile technique to prevent contamination. The infusion set is regulated under the FDA’s 510(k) clearance (K140131) and complies with the Medical Device Directive (MDD), with no third-party reprocessing indicated. Storage should follow manufacturer guidelines to maintain sterility and functionality.
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
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K140131 | Class II | Active |
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Manufacturer
- Manufacturer
- EMED Technologies Corporation
Sources (2)
- FDA 510(k) K140131 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026