Atlas FDA

NGT

40 FDA 510(k) clearances · Product code

147 daysmedian time to decision
280 days90th percentile
40clearances measured

FDA profile

Official device name
Saline, Vascular Access Flush
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5200
Medical specialty
General Hospital
FDA definition
Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.
Adverse events (MAUDE)
2021: 566 · 2022: 282 · 2023: 313 · 2024: 332 · 2025: 216 · 2026: 138
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe (K250884)Becton, Dickinson and Company2025-12-02
Praxiject™ SP 0.9% NaCl (K233623)Medxl, Inc.2024-02-27
Flush Syringe (Prefilled 0.9% normal saline solution) (K231724)Spm Medicare Pvt. , Ltd.2023-11-09
Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) (K231363)Hantech Medical Device Co., Ltd.2023-09-27
TK Pre-Filled Normal Saline Flush Syringe (K230756)Anhui Tiankang Medical Technology Co., Ltd.2023-08-12
Pre-Filled Normal Saline Flush Syringe (K223584)Anhui Tianyang Pharmaceutical Co., Ltd.2023-08-12
0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe (K231161)Becton, Dickinson and Company2023-07-21
Praxiject™ 0.9% NaCl (K231754)Medxl, Inc.2023-07-13
Pentaflush (K214080)Pentaferte Italia S.R.L.2022-07-20
AMSafe Pre-Filled Normal Saline Flush Syringe (K213522)Amsino International, Inc.2022-03-22
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 (K201286)Nurse Assist, LLC2020-08-11
Praxiject 0.9% NaCl (K192414)Medxl, Inc.2020-02-13
0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe (K191378)Medline Industries, Inc.2019-09-15
AMSafe(R) Pre-Filled Normal Saline Flush Syringe (K183473)Amsino International, Inc.2019-07-12
0.9% Sodium Chloride Injection, USP (K173348)Medline Industries, Inc.2018-06-21
Praxiject 0.9% NaCl (K171109)Medxl, Inc.2017-12-21
0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe (K161552)Becton, Dickinson and Company2017-02-02
0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe (K153481)Becton, Dickinson and Company2016-04-04
Normal Saline Flush (K150143)Nurse Assist, Inc.2015-08-31
0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride Injection, USP-3mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 5 mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 10 mL in 10 mL Syringe (K142620)Excelsior Medical Corporation2014-12-12
0.9% SODIUM CHLORIDE FLUSH SYRINGE (K133685)Am USA2014-08-13
0.9% SODIUM CHLORIDE INJECTION, USP BD POSIFLUSH; SP SYRINGE, SF SYRINGE (K141311)Becton, Dickinson and Company2014-07-25
0.9% SODIUM CHLORIDE INJECTION USP BD POSIFLUSH FLUSH SYRINGE, SF FLUSH SYRINGE (K121050)Becton, Dickinson & CO2013-02-07
MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY (K121262)Medefil, Inc.2012-09-20
IND DRUG HOME MULTI-PANEL TEST (2-5) IND MORPHINE HOME TEST (K121231)Ind Ndiagnostic, Inc.2012-07-30
0.9% SODIUM CHLORIDE FLISH SYRINGE (K120836)Am USA2012-07-12
AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE (K113555)Am USA2012-01-30
SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE (K103740)Spectra Medical Devices, Inc.2011-07-29
AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE (K111034)Am USA2011-07-14
SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311 (K101270)Excelsior Medical Corp.2011-02-10
FLUSH SYRINGE FILLED WITH 0.9% SODIUM CHLORIDE (K090882)Hospira, Inc.2010-04-23
MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGE (K091583)Medefil, Inc.2010-01-28
STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE (K082689)Spectra Medical Devices, Inc.2009-03-20
STERILE FIELD SALINE PRE-FILLED SYRINGE(S) (K082837)Excelsior Medical Corp.2008-12-18
KENDALL MONOJECT PRE-FILL ADVANCED 0.9%SODIUM CHLORIDE FLUSH SYRINGES FOR STERILE DELIVERY (K060339)Tyco Healthcare/Kendall2006-04-28
0.9% SODIUM CHLORIDE INJECTION, USP BD POSTFLUSH SF FLUSH SYRINGE (K042061)Becton Dickinson2004-08-26
MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PREFILL HEPRIN LOCK FLUSH SYRINGE (K032438)Tyco Healthcare2004-06-30
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 (K020996)Medefil, Inc.2002-06-24
MEDEFIL'S NORMAL SALINE FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL (K020999)Medefil, Inc.2002-06-20
MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE (K011283)The Kendall Company2001-10-15

Track NGT automatically

Every clearance here is in the API, with alerts when new ones post.