Ivac C80014 Y Solution Admin. Set
by Y 510(k)
Active
510(k) K843185
Overview
The IVAC C80014 Y Solution Administration Set is a Set, Administration, Intravascular device designed for the controlled delivery of intravenous fluids. It features a Y-connector configuration to facilitate simultaneous administration of multiple solutions or medications through a single intravenous access point, ensuring precise fluid management in clinical settings.
This set is intended for single-use in general hospital environments and is supplied sterile. It is classified under FDA product code FPA and was granted FDA 510(k) clearance (K843185) as substantially equivalent to a predicate device in 1984. Storage and handling must comply with sterile medical device protocols to maintain integrity before use.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK843185 | Date20 Sep 1984 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
Other devices from Y
Questions
What clinical scenarios is the IVAC C80014 Y Solution Administration Set designed to support in hospital settings?
The IVAC C80014 is specifically designed for controlled intravenous fluid administration in general hospital environments. Its Y-connector configuration allows simultaneous delivery of multiple fluids or medications through a single intravenous access point, making it ideal for scenarios like balanced electrolyte replacement, antibiotic administration alongside hydration, or when administering two incompatible medications that must be infused separately but via the same line. This setup helps streamline workflows while ensuring precise fluid management.
Is this administration set reusable, or is it intended for single-use only?
The IVAC C80014 Y Solution Administration Set is explicitly intended for single-use only. This is standard practice for sterile medical devices to prevent contamination and ensure patient safety. After use, the set must be discarded according to sterile medical device protocols, as reuse could compromise sterility and integrity.
How should I store this device before use to maintain its sterility?
To preserve sterility, the IVAC C80014 must be stored in its original, unopened packaging following the manufacturer’s instructions. The packaging is designed to protect the device from contamination, so avoid exposing it to moisture, direct sunlight, or extreme temperatures. Once opened, the set should be used immediately, and any unused portions must be discarded to prevent microbial growth or compromise of the sterile field.
Are there different sizes or models of this administration set, or is it a single standardized configuration?
The IVAC C80014 is described as a Y Solution Administration Set, which implies a standardized configuration with a Y-connector for dual-line administration. While the provided data does not specify multiple sizes or models, the Y-connector design suggests it is intended for compatibility with standard intravenous catheters and tubing sizes commonly used in hospital settings. For exact sizing details (e.g., tubing gauge or connector dimensions), refer to the manufacturer’s labeling or technical documentation.