# K171698: Smart Syringe

- Pathway: 510(k) (Special)
- Applicant: Osprey Medical, Inc.
- Decided: Jul 7, 2017 after 29 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: 11 generations back to K822536 (1982). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
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 4.

## Most influential descendants
- 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 Smart Syringe is to be used with the DyeVert Plus Contrast Reduction System or the Contrast Monitoring System. The DyeVert Plus Contrast Reduction 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 Contrast Monitoring System is to be used during angiographic or CT procedures requiring controlled infusion of radiopaque contrast media.

Source page: https://510kreport.com/device/K171698
Methodology: https://510kreport.com/methodology