NGTClass II

Saline, Vascular Access Flush

21 CFR 880.5200 / General Hospital

NGT is the FDA product code for Saline, Vascular Access Flush, a class II device type, regulated under 21 CFR 880.5200. FDA's definition for this code reads: "Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use". As of 2026-09-10, FDA records hold 40 510(k) clearances under this code, the most recent dated 2025-12-02, and 61 recalls.

Classification record

Product code: NGT
Device name: Saline, Vascular Access Flush
FDA definition: Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.
Regulation: 21 CFR 880.5200
Device class: Class II
Review panel: General Hospital
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 40
Ingested recalls: 61

Clearances, product code NGT

By decision year

40 clearances under product code NGT with a decision year between 2001 and 2025, 2023 the highest year at 6.

Show the numbers

510(k) clearances under FDA product code NGT by decision year
Year	Clearances
2001	1
2002	2
2004	2
2006	1
2008	1
2009	1
2010	2
2011	3
2012	4
2013	1
2014	3
2015	1
2016	1
2017	2
2018	1
2019	2
2020	2
2022	2
2023	6
2024	1
2025	1

Applicants with the most clearances

Product code NGT

Applicants holding the most 510(k) clearances under product code NGT
Applicant	Clearances
Becton Dickinson & Co	7
Am USA	4
Medefil, Inc.	4
Medxl, Inc.	4
Excelsior Medical LLC	3
Amsino International, Inc.	2
MEDLINE INDUSTRIES, LP - Northfield	2
Nurse Assist, LLC	2
Spectra Medical Devices, LLC	2
Anhui Tiankang Medical Technology Co., Ltd.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 41 companies shown, in name order