FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K111034 |
AM USA |
AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE |
07/14/2011 |
K113555 |
AM USA |
AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE |
01/30/2012 |
K213522 |
Amsino International, Inc. |
AMSafe Pre-Filled Normal Saline Flush Syringe |
03/22/2022 |
K183473 |
Amsino International, Inc. |
AMSafe(R) Pre-Filled Normal Saline Flush Syringe |
07/12/2019 |
K120836 |
AMUSA |
0.9% SODIUM CHLORIDE FLISH SYRINGE |
07/12/2012 |
K133685 |
AMUSA |
0.9% SODIUM CHLORIDE FLUSH SYRINGE |
08/13/2014 |
K230756 |
Anhui Tiankang Medical Technology Co., Ltd. |
TK Pre-Filled Normal Saline Flush Syringe |
08/12/2023 |
K223584 |
Anhui Tianyang Pharmaceutical Co., Ltd. |
Pre-Filled Normal Saline Flush Syringe |
08/12/2023 |
K042061 |
BECTON DICKINSON |
0.9% SODIUM CHLORIDE INJECTION, USP BD POSTFLUSH SF FLUSH SYRINGE |
08/26/2004 |
K121050 |
BECTON DICKINSON & CO. |
0.9% SODIUM CHLORIDE INJECTION USP BD POSIFLUSH FLUSH SYRINGE, SF FLUSH SYRINGE |
02/07/2013 |
K161552 |
Becton Dickinson and Company |
0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe |
02/02/2017 |
K153481 |
BECTON, DICKINSON AND COMPANY |
0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe |
04/04/2016 |
K141311 |
Becton, Dickinson and Company |
0.9% SODIUM CHLORIDE INJECTION, USP BD POSIFLUSH; SP SYRINGE, SF SYRINGE |
07/25/2014 |
K231161 |
Becton, Dickinson and Company |
0.9% Sodium Chloride Injection, USP BD PosiFlushÖ SF Saline Flush Syringe |
07/21/2023 |
K082837 |
EXCELSIOR MEDICAL CORP. |
STERILE FIELD SALINE PRE-FILLED SYRINGE(S) |
12/18/2008 |
K101270 |
EXCELSIOR MEDICAL CORP. |
SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311 |
02/10/2011 |
K142620 |
Excelsior Medical Corporation |
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 |
12/12/2014 |
K231363 |
Hantech Medical Device Co., Ltd. |
Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) |
09/27/2023 |
K090882 |
HOSPIRA, INC. |
FLUSH SYRINGE FILLED WITH 0.9% SODIUM CHLORIDE |
04/23/2010 |
K121231 |
IND NDIAGNOSTIC INC. |
IND DRUG HOME MULTI-PANEL TEST (2-5) IND MORPHINE HOME TEST |
07/30/2012 |
K220060 |
Jiangsu Caina Medical Co., Ltd. |
Pre-filled Syringe with Saline |
06/10/2022 |
K020996 |
MEDEFIL, INC. |
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 |
06/24/2002 |
K020999 |
MEDEFIL, INC. |
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 |
06/20/2002 |
K091583 |
MEDEFIL, INC. |
MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGE |
01/28/2010 |
K121262 |
MEDEFIL, INC. |
MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY |
09/20/2012 |
K173348 |
Medline Industries, Inc. |
0.9% Sodium Chloride Injection, USP |
06/21/2018 |
K191378 |
Medline Industries, Inc. |
0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe |
09/15/2019 |
K171109 |
MedXL Inc. |
Praxiject 0.9% NaCl |
12/21/2017 |
K192414 |
MedXL Inc. |
Praxiject 0.9% NaCl |
02/13/2020 |
K231754 |
MedXL Inc. |
PraxijectÖ 0.9% NaCl |
07/13/2023 |
K150143 |
NURSE ASSIST, INC. |
Normal Saline Flush |
08/31/2015 |
K201286 |
Nurse Assist, LLC |
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 |
08/11/2020 |
K214080 |
PENTAFERTE ITALIA S.R.L. |
Pentaflush |
07/20/2022 |
K103740 |
SPECTRA MEDICAL DEVICES, INC. |
SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE |
07/29/2011 |
K082689 |
SPECTRA MEDICAL DEVICES, INC. |
STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE |
03/20/2009 |
K011283 |
THE KENDALL COMPANY |
MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE |
10/15/2001 |
K032438 |
TYCO HEALTHCARE |
MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PREFILL HEPRIN LOCK FLUSH SYRINGE |
06/30/2004 |
K060339 |
TYCO HEALTHCARE/KENDALL |
KENDALL MONOJECT PRE-FILL ADVANCED 0.9%SODIUM CHLORIDE FLUSH SYRINGES FOR STERILE DELIVERY |
04/28/2006 |