FDA Product Code NGT: Saline, Vascular Access Flush
Maintaining catheter patency between infusions prevents thrombotic occlusion. FDA product code NGT covers saline flush solutions used for vascular access maintenance.
These sterile isotonic saline syringes are used to flush intravascular catheters before and after medication administration, removing residual drug, confirming catheter patency, and preventing thrombus formation in the catheter lumen.
NGT devices are Class II medical devices, regulated under 21 CFR 880.5200 and reviewed by the FDA General Hospital panel.
Leading manufacturers include Becton, Dickinson and Company, Amsino International, Inc. and Jiangsu Caina Medical Co.,Ltd.
FDA 510(k) Cleared Saline, Vascular Access Flush Devices (Product Code NGT)
About Product Code NGT - Regulatory Context
510(k) Submission Activity
41 total 510(k) submissions under product code NGT since 2001, with 41 receiving FDA clearance (average review time: 163 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 9 in the prior period.
FDA Review Time
Recent submissions under NGT have taken an average of 253 days to reach a decision - up from 161 days historically. Manufacturers should account for longer review timelines in current project planning.
NGT devices are reviewed by the General Hospital panel. Browse all General Hospital devices →