Multiple I.V. Sets
by C. B. Dumont Company, Inc. 510(k)
Active
510(k) K854804
Overview
Multiple I.V. sets are medical devices designed for the administration of intravenous fluids or medications. They consist of tubing and connectors that allow for the delivery of solutions from a container to a patient's vascular system.
These sets are intended for use in general hospital settings and are supplied as non-sterile, single-use devices. They are not MRI safe and are available in standard configurations as indicated by the product code FPA and K-number K854804, with authorization via FDA 510(k) clearance under decision code SESE.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK854804 | Date12 Feb 1986 | 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- Withdrawn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
- FPA
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5440
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from C. B. Dumont Company, Inc.
Questions
What are Multiple I.V. sets used for?
Multiple I.V. sets are designed for the administration of intravenous fluids or medications. They consist of tubing and connectors that allow delivery of solutions from a container to a patient's vascular system in general hospital settings.
Are Multiple I.V. sets sterile when supplied?
Multiple I.V. sets are supplied as non-sterile, single-use devices. They are intended for one-time use and must be sterilized by the user before application, as they are not provided in a sterile condition.
How are Multiple I.V. sets identified and authorized?
These sets are identified by product code FPA and K-number K854804. They received FDA 510(k) clearance under decision code SESE, indicating substantial equivalence to a legally marketed device.