# K140425: Contrast Modulation System

- Pathway: 510(k) (Traditional)
- Applicant: Osprey Medical, Inc.
- Decided: Jun 11, 2014 after 112 days
- Product code: DXT (Injector And Syringe, Angiographic)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K822536 (1982). 12 ancestors in all.
12 later devices descend from it; 4 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131478: Contrast Conservation System, Osprey Medical, Inc. (2013) Summary page 1.

## Most influential descendants
- 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
- K153141: DyeVert Contrast Modulation System (2016), 7 descendants of its own
- K161505: DyeVert NG Contrast Modulation System (2016), 6 descendants of its own

## Indications for use
The AVERT Contrast Modulation System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures with the following agents: lodixanol 270 or 320 mgl/ml, lohexol 300 or 350 mgl/ml, and lopamidol 370 mgI/ml.

Source page: https://510kreport.com/device/K140425
Methodology: https://510kreport.com/methodology