# DXT: Injector And Syringe, Angiographic

- Device class: 2; regulation: 21 CFR 870.1650; FDA's rule: 510(k) required
- FDA decisions: 211
- 510(k) review time 2021–2025: median 152 days (middle half 113–202)
- Recalls: 60 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2016: 8
- 2017: 7
- 2018: 9
- 2019: 4
- 2020: 3
- 2021: 1
- 2023: 1
- 2024: 4
- 2025: 1
- 2026: 7

## Most-cited predicates
- K072696: Ant Angiographic Syringes, Model (S) 100101,102,103,100201,202,203,204,100301,200101,201,202, 203,200301,101,102,202,301 (2008), cited by 6
- K912944: CT 8000 Digital Injection System (1992), cited by 6
- K033881: Medrad Stellant CT Injector System with Imaging System Interface Module (2004), cited by 5
- K984088: Optistar MR Injector System (1999), cited by 5
- K163054: DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System (2017), cited by 5
- K140425: Contrast Modulation System (2014), cited by 4
- K151960: Sterile High-pressure Angiographic Syringes for Single-use (2016), cited by 4
- K934086: Medrad Envision CT Injector and Qwik Fit Syringe (1995), cited by 4
- K051799: Disposable CT/MR Syringes for Nemoto Injectors (2005), cited by 4
- K093830: Medline Angiographic Control Syringe (2011), cited by 3

Source page: https://510kreport.com/product-code/DXT
Data by year (CSV): https://510kreport.com/product-code/DXT.csv