# K150485: AVERT Contrast Modulation System

- Pathway: 510(k) (Special)
- Applicant: Osprey Medical, Inc.
- Decided: Mar 26, 2015 after 30 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: 6 generations back to K822536 (1982). 13 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140425: Contrast Modulation System, Osprey Medical, Inc. (2014) Summary page 5.

## Most influential descendants
- K151300: AVERT 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
- K163054: DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System (2017), 5 descendants of its own
- K181936: DyeVert PLUS EZ Contrast Reduction System (2018), 2 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: Iodixanol 270 or 320 mgI/mL, Iohexol 300 or 350 mgI/mL and Iopamidol 300 or 370 mgI/mL.

Source page: https://510kreport.com/device/K150485
Methodology: https://510kreport.com/methodology