# K964782: Medrad Contrast Holder

- Pathway: 510(k) (Traditional)
- Applicant: Medrad, Inc.
- Decided: Feb 25, 1997 after 90 days
- Product code: FOX (Stand, Infusion)
- Device class: 1
- Regulation: 21 CFR 880.6990
- 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 K823270 (1982). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K823270: Heavy-Duty I.V. Stand, E.F. Brewer Co. (1982) Summary page 1.

## Indications for use
The Medrad Contrast Holders are an accessory device intended to be used in conjunction with Mexlrad injectors. The device is designed to aid in the transfer of common contrast media or flushing agents such as saline to the sytinge. Users of this device are to be medical professionals trained in CT, MR ,Angiographic Procedures, and are expected to have a good understanding of the events leading up to and including the use of the device. The Medrad Contrast Holder replaces the need for a separate contrast holder or Medrad Contrast Holder and is designed specifically for use with Medrad injectors.

Source page: https://510kreport.com/device/K964782
Methodology: https://510kreport.com/methodology