# K982123: Contrast Control Device

- Pathway: 510(k) (Traditional)
- Applicant: Medex, Inc.
- Decided: Jul 21, 1998 after 35 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
Longest line of descent: 1 generation back to K883318 (1988). 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)
- K883318: Valleylab I.V. Administration Sets, Valleylab, Inc. (1988) Summary page 1.
- K903493: Namic Contrast Savings Delivery System, North American Instrument Corp. (1991) Summary page 1.

## Indications for use
The Contrast Control Device (CCD) is intended for use in the IV delivery of contrast media during imaging procedures with a secondary intended use of conservation of contrast media.

Source page: https://510kreport.com/device/K982123
Methodology: https://510kreport.com/methodology