Ambulatory Infusion Pump
510(k) K890862
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK890862 | Date3 Aug 1989 | 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- Withdrawn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, 1 Oct 2026
This device is an infusion pump designed for the controlled delivery of fluids or medications to patients outside of a hospital setting. It falls under the classification of a pump, infusion and is intended for ambulatory use, allowing patients to receive continuous or intermittent infusions while maintaining mobility. The device is engineered to provide precise dosing, ensuring accurate administration of therapeutic agents in outpatient or home care environments.
The Ambulatory Infusion Pump is supplied as a reusable medical device, regulated under FDA 510(k) clearance (K890862) and classified as a Class II device (regulation number 880.5725). It is intended for use in general hospital settings, including neonatal, pediatric, and adult care, where small-volume infusions are required. The device is not specified as MRI-safe or single-use, and its operational specifications—such as battery life, flow rates, or connectivity—are not detailed in the provided data. Storage and maintenance instructions are not included in the regulatory submission.
Other devices from Medfusion, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Medfusion Ambulatory Infusion Pump used for?
The Medfusion Ambulatory Infusion Pump is designed for controlled delivery of fluids or medications outside of a hospital, enabling continuous or intermittent infusions while patients remain mobile. It is specifically intended for general hospital use, including neonatal, pediatric, and adult care, where small-volume infusions are required.
Is the Medfusion Ambulatory Infusion Pump single-use or reusable?
The Medfusion Ambulatory Infusion Pump is a reusable medical device. Unlike single-use pumps, this model is engineered for repeated use in clinical settings, provided it undergoes proper maintenance and cleaning as per manufacturer guidelines.
What regulatory approval does this infusion pump hold?
The Medfusion Ambulatory Infusion Pump holds FDA 510(k) clearance under the reference number K890862. It is classified as a Class II device under regulation number 880.5725, indicating it has been determined to be substantially equivalent to a legally marketed device.
Can this pump be used in MRI environments?
The provided data does not specify whether the Medfusion Ambulatory Infusion Pump is MRI-safe. If MRI compatibility is required, it is essential to consult the manufacturer’s documentation or verify compatibility directly with Medfusion, Inc.
What types of settings is this pump intended for?
This device is intended for use in general hospital settings, including neonatal, pediatric, and adult care environments. It is particularly suited for outpatient or home care scenarios where patients need controlled fluid or medication delivery while maintaining mobility.