# K142081: Contrast Monitoring System Display, Contrast Monitoring System Syringes

- Pathway: 510(k) (Traditional)
- Applicant: Osprey Medical, Inc.
- Decided: Dec 12, 2014 after 134 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: 1 generation back to K093830 (2011). 1 ancestor in all.
6 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093830: Medline Angiographic Control Syringe, Medline Industries, Inc. (2011) Summary page 5.

## Most influential descendants
- 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
- K190102: DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™ Plus EZ Contrast Reduction System (2019), 0 descendants of its own

## Indications for use
The device consists of a manual syringe and display to be used during Angiographic or CT procedures requiring controlled infusion of radiopaque contrast media.

Source page: https://510kreport.com/device/K142081
Methodology: https://510kreport.com/methodology