# K990711: Codan Chemospike

- Pathway: 510(k) (Traditional)
- Applicant: Codan US Corp.
- Decided: Apr 13, 1999 after 40 days
- Product code: LHI (Set, I.V. Fluid Transfer)
- 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 Chemospike is a transfer pin system for the safe preparation and withdrawal of medication and cytotoxic agents. It is designed to prevent the release of toxic aerosols during reconstitution of the drug in the vial and withdrawal of the drug from the vial.

Source page: https://510kreport.com/device/K990711
Methodology: https://510kreport.com/methodology