# K163054: DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Osprey Medical, Inc.
- Decided: Mar 8, 2017 after 127 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: 10 generations back to K822536 (1982). 19 ancestors in all.
5 later devices descend from it; 5 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)
- K161505: DyeVert NG Contrast Modulation System, Osprey Medical, Inc. (2016) Summary page 5.
- K142081: Contrast Monitoring System Display, Contrast Monitoring System Syringes, Osprey Medical, Inc. (2014) Summary page 5.

## Most influential descendants
- 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
- K190102: DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™ Plus EZ Contrast Reduction System (2019), 0 descendants of its own
- K183267: DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Contrast Reduction System, DyeTect™ Contrast Monitoring Disposable Kit, Smart Syringe, DyeVert™ PLUS EZ Contrast Reduction System (2018), 0 descendants of its own

## Indications for use
The device consists of a display to be used with the DyeVert Plus Disposable Kit or the Contrast monitoring Disposable Kit during angiographic or CT procedures requiring controlled infusion of radiopaque contrast media. The DyeVert™ Plus Contrast Modulation/Monitoring System consists of a Display and DyeVert Plus Disposable Kit. The system is to be used for contrast volume reduction and for the monitoring of radiopaque contrast media during angiographic or CT procedures with the following agents: Iodixanol 270 or 320 mgI/mL, Iohexol 300 or 350 mgI/mL and Iopamidol 370 mgI/mL. The device consists of a Smart Syringe and Pressure Module to be used with the Contrast Monitoring Display during angiographic or CT procedures requiring controlled infusion of radiopaque contrast media.

Source page: https://510kreport.com/device/K163054
Methodology: https://510kreport.com/methodology