Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

NGT · Predicate Candidate Screening

40 FDA 510(k) clearances under this product code; the 50 most recent screened below.

147 daysmedian FDA review time

280 days90th percentile

40clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K250884	0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syrin	Becton, Dickinson and Company	2025-12-02	253	0
K233623	Praxiject™ SP 0.9% NaCl	Medxl, Inc.	2024-02-27	106	0
K231724	Flush Syringe (Prefilled 0.9% normal saline solution)	Spm Medicare Pvt. , Ltd.	2023-11-09	149	0
K231363	Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models	Hantech Medical Device Co., Ltd.	2023-09-27	139	0
K230756	TK Pre-Filled Normal Saline Flush Syringe	Anhui Tiankang Medical Technology Co., Ltd.	2023-08-12	145	0
K223584	Pre-Filled Normal Saline Flush Syringe	Anhui Tianyang Pharmaceutical Co., Ltd.	2023-08-12	254	0
K231161	0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline	Becton, Dickinson and Company	2023-07-21	88	0
K231754	Praxiject™ 0.9% NaCl	Medxl, Inc.	2023-07-13	28	0
K214080	Pentaflush	Pentaferte Italia S.R.L.	2022-07-20	205	0
K213522	AMSafe Pre-Filled Normal Saline Flush Syringe	Amsino International, Inc.	2022-03-22	139	0
K201286	0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery	Nurse Assist, LLC	2020-08-11	89	2
K192414	Praxiject 0.9% NaCl	Medxl, Inc.	2020-02-13	162	0
K191378	0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe	Medline Industries, Inc.	2019-09-15	115	0
K183473	AMSafe(R) Pre-Filled Normal Saline Flush Syringe	Amsino International, Inc.	2019-07-12	210	0
K173348	0.9% Sodium Chloride Injection, USP	Medline Industries, Inc.	2018-06-21	239	1
K171109	Praxiject 0.9% NaCl	Medxl, Inc.	2017-12-21	251	0
K161552	0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe	Becton, Dickinson and Company	2017-02-02	241	1
K153481	0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe	Becton, Dickinson and Company	2016-04-04	123	0
K150143	Normal Saline Flush	Nurse Assist, Inc.	2015-08-31	221	1
K142620	0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe	Excelsior Medical Corporation	2014-12-12	87	0
K133685	0.9% SODIUM CHLORIDE FLUSH SYRINGE	Am USA	2014-08-13	254	1
K141311	0.9% SODIUM CHLORIDE INJECTION, USP BD POSIFLUSH; SP SYRINGE	Becton, Dickinson and Company	2014-07-25	66	0
K121050	0.9% SODIUM CHLORIDE INJECTION USP BD POSIFLUSH FLUSH SYRING	Becton, Dickinson & CO	2013-02-07	307	1
K121262	MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD REA	Medefil, Inc.	2012-09-20	147	0
K121231	IND DRUG HOME MULTI-PANEL TEST (2-5) IND MORPHINE HOME TEST	Ind Ndiagnostic, Inc.	2012-07-30	97	0
K120836	0.9% SODIUM CHLORIDE FLISH SYRINGE	Am USA	2012-07-12	114	2
K113555	AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE	Am USA	2012-01-30	60	1
K103740	SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE	Spectra Medical Devices, Inc.	2011-07-29	219	1
K111034	AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE	Am USA	2011-07-14	92	2
K101270	SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311	Excelsior Medical Corp.	2011-02-10	280	0
K090882	FLUSH SYRINGE FILLED WITH 0.9% SODIUM CHLORIDE	Hospira, Inc.	2010-04-23	388	3
K091583	MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGE	Medefil, Inc.	2010-01-28	240	1
K082689	STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE	Spectra Medical Devices, Inc.	2009-03-20	186	1
K082837	STERILE FIELD SALINE PRE-FILLED SYRINGE(S)	Excelsior Medical Corp.	2008-12-18	83	0
K060339	KENDALL MONOJECT PRE-FILL ADVANCED 0.9%SODIUM CHLORIDE FLUSH	Tyco Healthcare/Kendall	2006-04-28	77	11
K042061	0.9% SODIUM CHLORIDE INJECTION, USP BD POSTFLUSH SF FLUSH SY	Becton Dickinson	2004-08-26	24	13
K032438	MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH	Tyco Healthcare	2004-06-30	328	22
K020996	MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE IN VARIOUS FILL SIZES -	Medefil, Inc.	2002-06-24	88	0
K020999	MEDEFIL'S NORMAL SALINE FLUSH SYRINGE IN VARIOUS FILL SIZES	Medefil, Inc.	2002-06-20	84	0
K011283	MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE	The Kendall Company	2001-10-15	171	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda