# K052744: C2000 Automated Manifold Kit

- Pathway: 510(k) (Special)
- Applicant: Acist Medical Systems, Inc.
- Decided: Dec 16, 2005 after 77 days
- Product code: DXT (Injector And Syringe, Angiographic)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K903493 (1991). 5 ancestors in all.
14 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984231: Angiographic Contrast Management System, Model Part a and Part B, Invasatec (2000) Summary page 1.

## Most influential descendants
- K131478: Contrast Conservation System (2013), 13 descendants of its own
- K140425: Contrast Modulation System (2014), 12 descendants of its own
- K150485: AVERT Contrast Modulation System (2015), 10 descendants of its own
- K151300: AVERT Contrast Modulation System (2015), 8 descendants of its own
- K151746: Dyevert Contrast Modulation System (2015), 8 descendants of its own

## Recalls of this device
- Dec 21, 2015 · Class II · Z-0744-2016: Reports related to ingress of air into the manifold.

## Indications for use
The ACIST Angiographic Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.

Source page: https://510kreport.com/device/K052744
Methodology: https://510kreport.com/methodology