500 Infuser
by Excel Medical, Inc. 510(k)
Active
510(k) K914988
Overview
The 500 Infuser is an infusion pump used for the controlled delivery of fluids, including intravenous medications and nutrition, in a clinical setting. It is classified as a Class 2 medical device and is designed to operate as a general hospital infusion system. The device is intended to provide accurate and consistent flow rates to support patient therapy.
The 500 Infuser is supplied by Excel Medical, Inc. and is intended for single use in accordance with its regulatory filing. It is regulated under FDA product code FRN and received 510(k) clearance with the decision of substantial equivalence. The device is not described as MRI safe, and specific storage conditions are not detailed in the available specifications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK914988 | Date6 Apr 1992 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
-
- Terminated Z-0870-06
Potential for alarm failure when the 140 pump completes infusion and/or the pump encounters a mid-infusion occlusion, when used in the 140 mode with a 140cc syringe. The ESP Pump works correctly when used in 60 mode with a 60cc syringe or smaller.
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
Other devices from Excel Medical, Inc.
Questions
What is the 500 Infuser used for?
The 500 Infuser is an infusion pump designed for the controlled delivery of fluids, including intravenous medications and nutrition, in a clinical setting. It is intended to provide accurate and consistent flow rates to support patient therapy.
How is the 500 Infuser supplied?
The 500 Infuser is supplied by Excel Medical, Inc., based in Asbury Park, NJ. It is intended for single use in accordance with its regulatory filing.
Is the 500 Infuser reusable?
No, the 500 Infuser is intended for single use. This is specified in its regulatory filing to ensure patient safety and device integrity.
What are the storage requirements for the 500 Infuser?
Specific storage conditions for the 500 Infuser are not detailed in the available specifications. Users should refer to the manufacturer's labeling or contact Excel Medical, Inc. for storage guidance.
What is the regulatory status of the 500 Infuser?
The 500 Infuser is a Class 2 medical device regulated under FDA product code FRN. It received 510(k) clearance with a decision of substantial equivalence, indicating it is as safe and effective as a legally marketed predicate device.