Provider IV. Model 5000 Infusion Device
510(k) K871806
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK871806 | Date22 Oct 1987 | 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- Withdrawn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, 23 Sep 2026
The Provider IV. Model 5000 Infusion Device is an infusion pump used in a health care facility. It is classified as a Class 2 General Hospital device.
This device is regulated under FDA 510(k) clearance K871806. It is a traditional 510(k) submission manufactured by Pancretec, Inc.
Other devices from Pancretec, Inc.
Questions
AI-generated answers, 23 Sep 2026
What is the primary use of the Provider IV. Model 5000?
The Provider IV. Model 5000 is an infusion pump intended for use within a health care facility to assist in the delivery of fluids or medications.
How is this device regulated?
This device is classified as a Class 2 General Hospital device and is regulated under FDA 510(k) clearance number K871806, which was granted following a traditional 510(k) submission.
Who is the manufacturer of this infusion pump?
The Provider IV. Model 5000 Infusion Device is manufactured by Pancretec, Inc., located in San Diego, California.