IV Administration Set FPA
FDA 510(k)Class II (US FDA 510(k))
by Medex, Inc.
Identifiers
- 510(k) Number
- K944208 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 IV Administration Set FPA is a medical device classified as an intravenous administration set, designed for the controlled delivery of fluids, medications, or nutrients directly into a patient’s bloodstream. It incorporates a 15-micron fluid filter to remove particulates, an air stop filter to prevent air entrainment, and a drip chamber for precise flow adjustment. The tubing is kink-resistant and free of DEHP, ensuring reliability and safety during infusion.
This set is supplied as a single-use, non-sterile device intended for use in general hospital settings. It includes a 20-drop chamber and may feature vented or non-vented configurations, along with optional SmartSite needle-free valves for spill-free connections. Storage and handling must comply with standard sterile processing protocols, and its regulatory status includes FDA 510(k) clearance under K944208, filed in 1994. No additional sterilisation or reprocessing is indicated.
Frequently asked questions
What is the IV Administration Set FPA designed for?
The IV Administration Set FPA is specifically designed for the controlled delivery of fluids, medications, or nutrients directly into a patient’s bloodstream in general hospital settings. Its features—including a 15-micron fluid filter to remove particulates, an air stop filter to prevent air entrainment, and a 20-drop drip chamber for precise flow adjustment—ensure safe and reliable infusion therapy. The tubing is also kink-resistant and free of DEHP, a phthalate commonly found in plasticizers, which helps reduce the risk of complications during use.
Is the IV Administration Set FPA single-use or reusable?
The IV Administration Set FPA is intended for single-use only. It is supplied as a non-sterile device, meaning it is not pre-sterilized for clinical use. If sterilization is required before administration, it must be handled according to standard sterile processing protocols. Reuse is not recommended or supported by the manufacturer, as this could compromise patient safety and device integrity.
What configurations are available for the IV Administration Set FPA?
The IV Administration Set FPA is available in vented and non-vented configurations, allowing flexibility depending on clinical needs. Additionally, it may include optional SmartSite needle-free valves, which provide spill-free connections and reduce the risk of needle-stick injuries. The set also features a 20-drop drip chamber for accurate flow rate monitoring.
How should the IV Administration Set FPA be stored?
Since the IV Administration Set FPA is supplied as a non-sterile device, storage must follow standard sterile processing protocols if sterilization is required before use. The packaging should remain intact until immediately before administration to prevent contamination. If the set is not pre-sterilized, it should be handled in a clean environment, and any sterilization process (e.g., ethylene oxide or autoclave) must comply with regulatory guidelines to ensure safety and efficacy. Always check the manufacturer’s instructions for specific storage recommendations.
What regulatory clearance does the IV Administration Set FPA hold?
The IV Administration Set FPA holds FDA 510(k) clearance under the reference number K944208, filed in 1994. This clearance was granted under the Traditional 510(k) Review Process by the FDA’s Orthopaedic Devices Panel (HO), with a decision classification of Substantially Equivalent (SESE). The device was determined to be substantially equivalent to a legally marketed predicate device for use in general hospital settings. No additional sterilization or reprocessing is indicated beyond standard sterile processing protocols if required.
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. Sources consulted: IV ADMINISTRATION SET FPA (K944208) — FDA 510(k) | Innolitics, IV ADMINISTRATION SET FPA 510(k) K944208 - FDA.report, IV Administration Sets | MEDEX, MEDEX™ IV Administration Set, 20 Drop, Vented/Non-vented, (1) SmartSite ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K944208 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medex, Inc.
Sources (1)
- FDA 510(k) K944208 24 fields · synced Oct 1, 2026