Vascular Access Port Continuous Infusion Sets
by Florida Infusion Services, Inc. 510(k)
Active
510(k) K904886
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK904886 | Date11 Jan 1991 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FPA
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5440
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Vascular Access Port Continuous Infusion Sets are classified as intravascular administration sets, designed to deliver fluids, medications, or nutrients from a reservoir to a patient’s vascular system via a needle or catheter inserted into a vein. These sets are engineered to provide continuous infusion through a vascular access port, ensuring reliable and controlled fluid administration for extended periods. The device facilitates precise dosing and monitoring, which is critical in clinical settings requiring sustained therapy.
These infusion sets are intended for single-use only and must be handled under aseptic conditions to maintain sterility. They are regulated under the FDA’s 510(k) clearance process, with the specific product code FPA under 21 CFR 880.5440. Supplied sterile and packaged for clinical use, they are designed for compatibility with standard vascular access ports and infusion pumps. No additional regulatory approvals beyond the FDA clearance are stated in the device data.
Questions
AI-generated answers, 1 Oct 2026
What is the primary purpose of the Vascular Access Port Continuous Infusion Sets?
These infusion sets are designed to deliver fluids, medications, or nutrients continuously from a reservoir to a patient’s vascular system via a needle or catheter inserted into a vein. They are specifically engineered to work with vascular access ports, ensuring reliable and controlled administration for prolonged therapy, which is essential in clinical settings requiring sustained treatment.
Are the Vascular Access Port Continuous Infusion Sets intended for single-use or reuse?
The device is explicitly intended for single-use only. This design ensures patient safety by preventing contamination and maintaining sterility, which is critical for intravascular administration to avoid infections or complications.
How are the infusion sets supplied, and what sterility measures must be followed?
The sets are supplied sterile and pre-packaged for clinical use. To maintain sterility, they must be handled under aseptic conditions throughout the entire process—from unpacking to administration—since they are not intended for reuse.
What regulatory pathway does this device follow, and what is its product code?
The Vascular Access Port Continuous Infusion Sets are regulated under the FDA’s 510(k) clearance process, specifically classified under product code FPA in 21 CFR 880.5440. This clearance confirms that the device meets FDA standards for safety and effectiveness as an intravascular administration set.
Are these infusion sets compatible with standard infusion pumps and vascular access ports?
Yes, the sets are explicitly designed for compatibility with standard vascular access ports and infusion pumps. This ensures seamless integration into existing clinical workflows, allowing for precise dosing and continuous infusion as required by healthcare providers.