# K960921: Codan Medlon BC110 Vial Adapter Codan Spike

- Pathway: 510(k) (Traditional)
- Applicant: Codan Medlon, Inc.
- Decided: Apr 17, 1996 after 42 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
Longest line of descent: 1 generation back to K901063 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K901063: Luer Lock Transfer Pin, Acacia, Inc. (1990) Summary page 1.
- K925401: IV Fluid Transfer Pin, B. Braun of America, Inc. (1993) Summary page 1.

## Indications for use
The CODAN Spike is designed to be used to transfer medication from a vial to a syringe and from syringe to an 1V set.

Source page: https://510kreport.com/device/K960921
Methodology: https://510kreport.com/methodology