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, Medxl, Inc. and Medline Industries, Inc..
41
Total
41
Cleared
163d
Avg days
2001
Since
Declining activity -
1 submissions in the last 2 years
vs 8 in the prior period
Review times increasing: avg
253d
recently vs 161d historically
FDA 510(k) Cleared Saline, Vascular Access Flush Devices (Product Code NGT)
41 devices
Cleared
Dec 02, 2025
0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe
Becton, Dickinson and Company
General Hospital
253d
Cleared
Feb 27, 2024
Praxiject™ SP 0.9% NaCl
Medxl, Inc.
General Hospital
106d
Cleared
Nov 09, 2023
Flush Syringe (Prefilled 0.9% normal saline solution)
Spm Medicare Pvt. , Ltd.
General Hospital
149d
Cleared
Sep 27, 2023
Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)
Hantech Medical Device Co., Ltd.
General Hospital
139d
Cleared
Aug 12, 2023
Pre-Filled Normal Saline Flush Syringe
Anhui Tianyang Pharmaceutical Co., Ltd.
General Hospital
254d
Cleared
Aug 12, 2023
TK Pre-Filled Normal Saline Flush Syringe
Anhui Tiankang Medical Technology Co., Ltd.
General Hospital
145d
Cleared
Jul 21, 2023
0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe
Becton, Dickinson and Company
General Hospital
88d
Cleared
Jul 13, 2023
Praxiject™ 0.9% NaCl
Medxl, Inc.
General Hospital
28d
Cleared
Jul 20, 2022
Pentaflush
Pentaferte Italia S.R.L.
General Hospital
205d
Cleared
Jun 10, 2022
Pre-filled Syringe with Saline
Jiangsu Caina Medical Co.,Ltd
General Hospital
151d
Cleared
Mar 22, 2022
AMSafe Pre-Filled Normal Saline Flush Syringe
Amsino International, Inc.
General Hospital
139d
Cleared
Aug 11, 2020
0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch
Nurse Assist, LLC
General Hospital
89d
Cleared
Feb 13, 2020
Praxiject 0.9% NaCl
Medxl, Inc.
General Hospital
162d
Cleared
Sep 15, 2019
0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe
Medline Industries, Inc.
General Hospital
115d
Cleared
Jul 12, 2019
AMSafe(R) Pre-Filled Normal Saline Flush Syringe
Amsino International, Inc.
General Hospital
210d
Cleared
Jun 21, 2018
0.9% Sodium Chloride Injection, USP
Medline Industries, Inc.
General Hospital
239d
Cleared
Feb 02, 2017
0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe
Becton, Dickinson and Company
General Hospital
241d
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 8 in the prior period.
FDA 510(k) Review Time - NGT Product Code
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 →