Identifiers
- 510(k) Number
- K142433 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 Hospira Extension Set is a microbore intravenous extension tubing device (Product Code: FPA) designed to facilitate intravenous fluid and medication administration. It connects primary infusion lines to secondary infusion lines, enabling flexible fluid pathways while maintaining sterility and flow integrity. The device includes a female adapter, a slide clamp, and a T-connector with a pre-pierced resealable injection site for intermittent medication administration. Its slim bore (0.054” internal diameter) minimizes resistance to flow while supporting precise dosing requirements in hospital settings.
This extension set is supplied sterile in a sealed package and is intended for single-use only. It is compatible with standard intravenous administration systems and may be used in general hospital environments. The device is non-magnetic and does not contain DEHP (di(2-ethylhexyl) phthalate) in its formulation, ensuring compatibility with sensitive patient populations. Authorized under FDA 510(k) clearance (K142433), it adheres to regulatory standards for intravenous accessories. Nominal lengths vary (e.g., 5.25”, 13”, or 36” as referenced in specifications), with priming capacities up to approximately 1.5 mL for ease of use.
Frequently asked questions
What is the Hospira Extension Set used for?
The Hospira Extension Set connects primary and secondary intravenous lines to create flexible fluid pathways. Its microbore design (0.054” internal diameter) reduces flow resistance while maintaining precise dosing for medications and fluids in hospital environments. The included T-connector with a pre-pierced injection site also allows intermittent medication administration without disrupting the primary infusion.
How is the Hospira Extension Set supplied and prepared for use?
The extension set is supplied sterile in a sealed package, ensuring sterility until first use. It is intended for single-use only, meaning each unit should be discarded after one patient administration to prevent contamination. Before use, verify the package integrity and follow standard aseptic techniques to attach it to compatible intravenous administration systems.
What lengths and priming capacities are available for the Hospira Extension Set?
Nominal lengths include 5.25”, 13”, and 36” to accommodate various clinical workflows. The priming capacity (volume required to fill the tubing before use) is up to approximately 1.5 mL, which helps ensure efficient fluid delivery without air embolism risks. The choice of length depends on the specific infusion setup and patient needs.
Is the Hospira Extension Set reusable or must it be discarded after use?
The Hospira Extension Set is designed for single-use only. Reusing it increases the risk of contamination, infection, or compromised sterility, which could harm patients. Always discard the set after one use and open a new sterile unit for subsequent administrations to maintain safety and compliance with medical device standards.
Does the Hospira Extension Set contain DEHP, and what does that mean for patients?
No, the Hospira Extension Set does not contain DEHP (di(2-ethylhexyl) phthalate), a plasticizer found in some medical tubing. This makes it suitable for use with sensitive patient populations, such as neonates or individuals with known sensitivities to phthalates. DEHP-free formulations reduce potential chemical exposure risks during intravenous therapy.
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: Hospira Extension Set - Microbore with T-Connector, 5.25", Hospira 12658-28 - Microbore Extension Set, w/Option-Lok 36" LF 50/BX, Hospira Microbore Extension Sets - Medline, Hospira #14281-28 IV Extension Set Tubing - 13in, Y-Site, NDEHP Free ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142433 | Class II | Active |
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Manufacturer
- Manufacturer
- Hospira, Inc.
Sources (1)
- FDA 510(k) K142433 24 fields · synced Oct 1, 2026