# NGT: Saline, Vascular Access Flush

- Device class: 2; regulation: 21 CFR 880.5200; FDA's rule: 510(k) required
- FDA decisions: 41
- 510(k) review time 2021–2025: median 145 days (middle half 123–178)
- Recalls: 24 (6 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2015: 1
- 2016: 1
- 2017: 2
- 2018: 1
- 2019: 2
- 2020: 2
- 2022: 3
- 2023: 6
- 2024: 1
- 2025: 1

## Most-cited predicates
- K082837: Sterile Field Saline Pre-Filled Syringe (S) (2008), cited by 3
- K111034: AM Usa 0.9% Sodium Chloride Flush Syringe (2011), cited by 3
- K032438: Modification to: Monojet Prefill 0.9% Sodium Chloride Flush Syringe, Monojet Prefill Heprin Lock Flush Syringe (2004), cited by 2
- K171109: Praxiject 0.9% NaCl (2017), cited by 2
- K183473: AMSafe (R) Pre-Filled Normal Saline Flush Syringe (2019), cited by 2
- K192414: Praxiject 0.9% NaCl (2020), cited by 2
- K213522: AMSafe Pre-Filled Normal Saline Flush Syringe (2022), cited by 2
- K121050: 0.9% Sodium Chloride Injection Usp BD Posiflush Flush Syringe, SF Flush Syringe (2013), cited by 2
- K161552: 0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe (2017), cited by 2
- K020996: Medefil's Heparin I.V. Flush Syringe in Various Fill Sizes - 1 ML Fill in 6 ML Syringe LL; 2 ML Fill in 6 ML Syringe LL (2002), cited by 2

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