FMF · Class II · 21 CFR 880.5860

FDA Product Code FMF: Syringe, Piston

Under FDA product code FMF, piston syringes are cleared for the aspiration and injection of fluids in clinical settings.

These devices consist of a cylindrical barrel and a sliding plunger that creates suction or pressure to draw in or expel liquids. They are used for medication injection, wound irrigation, aspiration of body fluids, and enteral feeding across all care settings.

FMF devices are Class II medical devices, regulated under 21 CFR 880.5860 and reviewed by the FDA General Hospital panel.

Leading manufacturers include Bd Becton Dickinson Vacutainer Systems Preanalytic, Sherwood Medical Co. and Becton, Dickinson and Company.

753
Total
753
Cleared
124d
Avg days
1976
Since
753 devices
121–144 of 753
Cleared Apr 05, 2019
EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit)
K182268
Flat Medical Co., Ltd.
General Hospital · 227d
Cleared Mar 14, 2019
BD Plastipak Syringe
K182589
Becton, Dickinson and Company
General Hospital · 175d
Cleared Dec 17, 2018
NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)
K182387
Novo Nordisk, Inc.
General Hospital · 104d
Cleared Nov 20, 2018
Orbit Subretinal Delivery System
K182274
Orbit Biomedical, Inc.
Ophthalmic · 90d
Cleared Nov 06, 2018
Merit Syringe
K182216
Merit Medical Systems, Inc.
General Hospital · 83d
Cleared Nov 06, 2018
Merit Syringe
K182279
Merit Medical Systems, Inc.
General Hospital · 76d
Cleared Oct 23, 2018
BD Single Use, Hypodermic Syringe
K172670
Becton, Dickinson and Company
General Hospital · 413d
Cleared May 10, 2018
Graftgun Universal Graft Delivery System
K180937
SurGenTec, LLC
General Hospital · 30d
Cleared Mar 30, 2018
Nipro Syringe
K173029
Nipro Medical Corporation
General Hospital · 183d
Cleared Jan 31, 2018
Merit Syringe
K173601
Merit Medical Systems, Inc.
General Hospital · 71d
Cleared Aug 07, 2017
Merit Syringe
K171362
Merit Medical Systems, Inc.
General Hospital · 90d
Cleared Dec 19, 2016
BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin Syringe
K162081
Becton, Dickinson and Company
General Hospital · 145d
Cleared Jul 08, 2016
BD U-500 INSULIN SYRINGE
K151870
Becton, Dickinson and Company
General Hospital · 365d
Cleared Jul 08, 2016
LITe BIO Delivery System
K160978
Stryker Corporation
General Hospital · 92d
Cleared Dec 07, 2015
Merit 20 mL Syringe
K152783
Merit Medical Systems, Inc.
General Hospital · 73d
Cleared Sep 02, 2015
BD Single Use, Hypodermic Syringe
K151766
Becton, Dickinson and Company
General Hospital · 64d
Cleared Apr 23, 2015
ConMed Mixing and Delivery Kit
K142535
Conmed Corporation
General Hospital · 226d
Cleared Oct 17, 2014
Merit 10mL Syringe
K142636
Merit Medical Systems, Inc.
General Hospital · 30d
Cleared Aug 27, 2014
PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEM
K141762
Biomet, Inc.
General Hospital · 57d
Cleared Apr 14, 2014
NAMIC RCS SYRINGE
K140194
Navilyst Medical, Inc.
General Hospital · 77d
Cleared Aug 28, 2013
MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP)
K131641
Nipro Medical Corporation
General Hospital · 85d
Cleared Feb 14, 2013
MONOJECT 12ML SYRINGE
K130049
Nipro Medical Corporation
General Hospital · 37d
Cleared May 30, 2012
BD EMERALD SAF-T SINGLE USE, HYPODERMIC
K121283
Becton, Dickinson and Company
General Hospital · 30d
Cleared May 16, 2012
ARTHREX MIXING AND DELIVERY SYSTEM
K121124
Arthrex, Inc.
General Hospital · 33d