Flo-Gard VP
510(k) K884014
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK884014 | Date12 Dec 1988 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- FRN
- Device class
- Class II
- Regulation
- 21 CFR Part 880.5725
- Advisory committee
- General Hospital
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Flo-Gard VP is a volumetric infusion pump designed for controlled administration of intravenous fluids. It delivers precise, programmable flow rates to ensure accurate dosing in clinical settings, supporting a range of medical specialties including general hospital care.
This device is intended for single-use in hospital environments and is classified as a Class II medical device under FDA regulations. Supplied sterile, it operates in non-MRI environments and requires proper storage as per manufacturer guidelines. Authorized under FDA 510(k) clearance (K884014), it adheres to regulatory standards for infusion pumps (product code FRN)
Other devices from Baxter Healthcare Corp
Questions
AI-generated answers, 20 Sep 2026
Is the Flo-Gard VP pump designed for use in MRI environments, and if not, what are the implications for its use in hospitals with MRI facilities?
No, the Flo-Gard VP is explicitly designed for use in non-MRI environments. This means it should not be placed inside or near MRI scanners, as its operation could interfere with MRI imaging or be affected by the magnetic fields. Clinicians must ensure the pump is positioned outside MRI zones to avoid potential safety risks or imaging artifacts.
How should the Flo-Gard VP be stored to maintain its sterility and functionality, and is it intended for single-use only?
The Flo-Gard VP is supplied sterile and is intended for single-use only in hospital settings. Proper storage must follow Baxter Healthcare Corp’s guidelines to preserve sterility and functionality, typically involving clean, dry conditions away from direct sunlight or extreme temperatures. Discarding after one use ensures compliance with regulatory standards and infection control protocols.
What types of medical specialties or clinical settings is the Flo-Gard VP primarily intended for, and how does this relate to its programmable flow rates?
The Flo-Gard VP is authorized for use in general hospital care, supporting a broad range of medical specialties where precise intravenous fluid administration is critical. Its programmable flow rates allow clinicians to deliver accurate, controlled dosing—ideal for settings like emergency rooms, surgical units, or intensive care—where fluid therapy must be carefully monitored to avoid under- or overhydration.
Are there multiple models or sizes of the Flo-Gard VP, or is it a single-unit device with standardized specifications?
The data provided does not specify distinct models or sizes for the Flo-Gard VP, suggesting it is likely a single-unit device with standardized specifications for volumetric infusion. However, the extensive list of FEI numbers (Foreign Equipment Identifier) may indicate variations in regulatory filings or minor customizations, but these do not imply clinical differences in functionality or flow rates. Clarification from Baxter Healthcare would be needed for specific model inquiries.