# K190102: DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™ Plus EZ Contrast Reduction System

- Pathway: 510(k) (Traditional)
- Applicant: Osprey Medical, Inc.
- Decided: Oct 17, 2019 after 268 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: 12 generations back to K822536 (1982). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163054: DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System, Osprey Medical, Inc. (2017) Summary page 6.
- K181936: DyeVert PLUS EZ Contrast Reduction System, Osprey Medical, Inc. (2018) Summary page 6.

## Indications for use
DyeVert™ Plus Contrast Reduction System Smart Monitor The device consists of a Smart Monitor to be used with the DyeVert Plus Disposable Kit, DyeVert Plus EZ Disposable Kit or the DyeTect Contrast Monitoring Disposable Kit during angiographic or CT procedures requiring controlled infusion of radiopaque contrast media. DyeVert Plus Disposable Kit The DyeVert™ Plus Contrast Reduction System consists of a Monitor 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. DyeVert™ Plus EZ Contrast Reduction System Smart Monitor The device consists of a Smart Monitor to be used with the DyeVert Plus Disposable Kit, DyeVert Plus EZ Disposable Kit or the DyeTect Contrast Monitoring Disposable Kit during angiographic or CT procedures requiring controlled infusion of radiopaque contrast media. DyeVert Plus EZ Disposable Kit The DyeVert™ Plus EZ Contrast Reduction System consists of a Monitor and DyeVert Plus EZ 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. DyeTect™ Contrast Monitoring System Smart Monitor The device consists of a Smart Monitor to be used with the DyeVert Plus Disposable Kit, DyeVert Plus EZ Disposable Kit or the DyeTect Contrast Monitoring Disposable Kit during angiographic or CT procedures requiring controlled infusion of radiopaque contrast media. DyeTect Contrast Monitoring Disposable Kit The DyeTect Contrast Monitoring Disposable Kit consists of a Smart Syringe and Pressure Module to be used with the Monitor during angiographic or CT procedures requiring controlled infusion of radiopaque contrast media.

Source page: https://510kreport.com/device/K190102
Methodology: https://510kreport.com/methodology