# K961794: Fluid Administration Set - Contrast Manager

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Aug 1, 1996 after 84 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 K903493 (1991). 1 ancestor in all.
39 later devices descend from it; 6 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K903493: Namic Contrast Savings Delivery System, North American Instrument Corp. (1991) Summary page 1.

## Most influential descendants
- K984231: Angiographic Contrast Management System, Model Part a and Part B (2000), 20 descendants of its own
- K022431: Medrad Transfer Set (2002), 15 descendants of its own
- K052744: C2000 Automated Manifold Kit (2005), 14 descendants of its own
- K131478: Contrast Conservation System (2013), 13 descendants of its own
- K140425: Contrast Modulation System (2014), 12 descendants of its own

Source page: https://510kreport.com/device/K961794
Methodology: https://510kreport.com/methodology