# K153141: DyeVert Contrast Modulation System

- Pathway: 510(k) (Traditional)
- Applicant: Osprey Medical, Inc.
- Decided: Feb 4, 2016 after 97 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: 8 generations back to K822536 (1982). 16 ancestors in all.
7 later devices descend from it; 1 cites 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)
- K151746: Dyevert Contrast Modulation System, Osprey Medical, Inc. (2015) Summary page 5.
- K151300: AVERT Contrast Modulation System, Osprey Medical, Inc. (2015) Summary page 6.

## Most influential descendants
- 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
- K171698: Smart Syringe (2017), 1 descendant of its own
- K171217: DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System (2017), 1 descendant of its own

## Indications for use
The DyeVert™ Contrast Modulation System is to be used for the controlled infusion and contrast volume reduction 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 370 mgI/mL.

Source page: https://510kreport.com/device/K153141
Methodology: https://510kreport.com/methodology