Homepro II Volumetric Infusion Pump
by American Edwards Laboratories 510(k)
Active
510(k) K870444
Overview
The Homepro II Volumetric Infusion Pump is a volumetric infusion device designed to deliver controlled volumes of intravenous fluids or medications. It operates using a precise mechanism to regulate flow rates, ensuring accurate dosing for patient therapy in hospital settings. This device is categorized under infusion pumps and is intended for general hospital use, providing reliable fluid administration for continuous or intermittent treatment.
The Homepro II Volumetric Infusion Pump is a reusable medical device regulated under FDA 510(k) clearance (K870444) and classified as a Class II device under regulation number 880.5725. It is intended for use in general hospital environments and has received a 'Substantially Equivalent' decision from the FDA’s advisory committee (HO). No specific details regarding MRI compatibility, sterility, or storage conditions are provided.
Homepro II Volumetric Infusion Pump
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK870444 | Date17 Apr 1987 | 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- Withdrawn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
- FRN
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5725
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from American Edwards Laboratories
Questions
What is the Homepro II Volumetric Infusion Pump used for?
The Homepro II Volumetric Infusion Pump is designed to deliver controlled volumes of intravenous fluids or medications with precise flow regulation. This ensures accurate dosing for continuous or intermittent patient therapy in hospital environments, making it ideal for administering fluids or drugs where precise volume control is critical.
Is the Homepro II Volumetric Infusion Pump reusable or single-use?
The Homepro II Volumetric Infusion Pump is a reusable medical device. Unlike single-use pumps, it is intended for repeated use in hospital settings, provided it undergoes proper cleaning, maintenance, and sterilization between uses as per manufacturer guidelines.
What regulatory status does the Homepro II Volumetric Infusion Pump hold?
The Homepro II Volumetric Infusion Pump holds FDA 510(k) clearance under the reference number K870444. It is classified as a Class II device under regulation number 880.5725 and was granted a 'Substantially Equivalent' decision by the FDA’s advisory committee (HO) for general hospital use.
Are there specific storage or handling instructions for the Homepro II Volumetric Infusion Pump?
The provided device data does not specify detailed storage or handling instructions. However, as a reusable medical device, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Follow the manufacturer’s maintenance protocols to ensure proper functionality and longevity.
What types of fluids or medications can be administered using the Homepro II Volumetric Infusion Pump?
The Homepro II Volumetric Infusion Pump is intended for delivering intravenous fluids or medications in controlled volumes. While it is versatile for general hospital use, the specific types of fluids or medications should be compatible with the pump’s tubing and flow mechanisms. Always refer to the manufacturer’s instructions for compatibility and usage guidelines.