Solution Set/Extension Set
by Baxter Healthcare Corporation 510(k)
Active
510(k) K142011
Overview
This device is a Solution Set/Extension Set, classified under product code FPA, designed for intravenous (IV) fluid administration. It consists of tubing and connectors that facilitate the transfer of fluids from a primary infusion bag or container to a patient, ensuring controlled delivery of medications or solutions. The set may include features such as Duo-Vent spikes for secure attachment to infusion containers, enhancing usability in clinical settings.
The Solution Set/Extension Set is intended for single-use in hospital environments, as indicated by its classification under the General Hospital advisory committee. It is supplied sterile and must be used within the parameters outlined in its specifications to maintain safety and efficacy. The device is regulated under FDA clearance via a 510(k) submission (K142011), with a Special clearance type, and is distributed by Baxter Healthcare Corporation. Storage and handling should adhere to manufacturer guidelines to preserve sterility and functionality.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK142011 | Date18 Aug 2014 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 24 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
Other devices from Baxter Healthcare Corporation
Questions
What is the Baxter IV Extension Set FPA used for?
The Baxter IV Extension Set FPA is designed for intravenous (IV) fluid administration in hospital environments. It connects a primary infusion bag or container to a patient, allowing controlled delivery of medications or solutions. The Duo-Vent spikes included ensure a secure attachment to infusion containers, reducing the risk of leaks or contamination during use.
Is the Baxter IV Extension Set FPA sterile and single-use?
Yes, the Baxter IV Extension Set FPA is supplied sterile and intended for single-use only. This ensures patient safety by preventing cross-contamination and maintaining the integrity of the infusion process. After use, the set must be discarded to comply with sterile medical device protocols.
How should the Baxter IV Extension Set FPA be stored to maintain sterility?
The set should be stored in its original, unopened packaging to preserve sterility. Keep it in a clean, dry environment away from direct sunlight, extreme temperatures, or sources of contamination. Follow Baxter Healthcare Corporation’s guidelines for storage to ensure the tubing and connectors remain functional and safe for use.
What regulatory clearance does the Baxter IV Extension Set FPA hold?
The Baxter IV Extension Set FPA holds FDA clearance through a 510(k) submission (K142011), classified under the Special clearance type. It is categorized under product code FPA and falls under the General Hospital advisory committee, indicating its intended use in hospital settings.
Are there different sizes or models available for the Baxter IV Extension Set FPA?
The provided data does not specify multiple sizes or models for this particular extension set. However, Baxter Healthcare Corporation may offer variations in length or connector types for different clinical needs. For precise specifications, refer to the manufacturer’s product documentation or contact their technical support.