# K991103: Modification to Acist CL 100H

- Pathway: 510(k) (Traditional)
- Applicant: Acist Medical Systems
- Decided: May 31, 2000 after 426 days
- Product code: DXT (Injector And Syringe, Angiographic)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K822536 (1982). 3 ancestors in all.
19 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963982: Acist Angiographic Injector, Invasatec (1997) Summary page 1.
- K984058: Acist Injector System, Model CL100 H, Acist Medical Systems (1999) 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
- Nov 10, 2008 · Not classified · Z-0643-2009: Multiple Injections may result. It has been determined that when using the ACIST CVi Angiographic Injection system to synchronize with the Toshiba Infinix -i cardiovascular x-ray system there is an in
- May 19, 2004 · Not classified · Z-1002-04: Some of the sterile product packages were inadequately sealed prior to sterilization and as a result the package contents may not be sterile.
- Oct 2, 2003 · Not classified · Z-0064-04: Some of the automated manifold's 2.5 inch high-pressure lines for radiopaque contrast media, used in angiographic procedures, have separated where they are bonded to the manifold body of the device al

## Indications for use
The Acist ™ CMS-2000 Angiographic Injection System with Contrast Management is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.

Source page: https://510kreport.com/device/K991103
Methodology: https://510kreport.com/methodology