# K042693: IV Administration Set B400 SP

- Pathway: 510(k) (Traditional)
- Applicant: Codan US Corp.
- Decided: Oct 21, 2004 after 21 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The CODAN IV Administration Set B400 Sp is indicated to facilitate the infusion of IV fluids from a plastic bag or solution container, into the patient.

Source page: https://510kreport.com/device/K042693
Methodology: https://510kreport.com/methodology