AVI Model 285CI Infusion Pump
510(k) K920681
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK920681 | Date6 Apr 1992 | 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- Withdrawn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, 6 Oct 2026
An infusion pump is a device designed to deliver fluids, such as nutrients and medications, into a patient's body in controlled amounts. The AVI Model 285CI Infusion Pump is a Class II medical device cleared by the FDA under 510(k) K920681, substantially equivalent to a legally marketed predicate device.
It is intended for use in general hospital settings and is supplied as a reusable device. The pump operates under special controls for infusion pumps and is regulated under FDA regulation number 880.5725 with product code FRN.
Other devices from 3M Health Care, Ltd.
Questions
AI-generated answers, 6 Oct 2026
What is the AVI Model 285CI Infusion Pump used for?
The AVI Model 285CI Infusion Pump is designed to deliver fluids such as nutrients and medications into a patient's body in controlled amounts, intended for use in general hospital settings as stated in the device description.
Is the AVI Model 285CI Infusion Pump reusable or single-use?
The AVI Model 285CI Infusion Pump is supplied as a reusable device, meaning it can be used multiple times following appropriate cleaning and maintenance procedures, as specified in the device description.
What regulatory pathway was used for the AVI Model 285CI Infusion Pump?
The AVI Model 285CI Infusion Pump was cleared by the FDA through the traditional 510(k) process under K920681, demonstrating substantial equivalence to a legally marketed predicate device, as indicated in the device data.