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.

756
Total
756
Cleared
124d
Avg days
1976
Since
756 devices
121–144 of 756
Cleared Sep 27, 2019
EpiFaith Syringe
K192421
Flat Medical Co., Ltd.
Anesthesiology · 23d
Cleared Sep 12, 2019
Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use
K190002
Shanghai Kohope Medical Devices Co., Ltd.
General Hospital · 253d
Cleared Sep 06, 2019
Sure-Fine Insulin Syringes
K191531
Shina Med Corporation
General Hospital · 88d
Cleared Sep 03, 2019
5cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc Neuraxial Additive Slip Tip Glass Syringe,10cc Neuraxial Slip Tip Glass Syringe,10cc Neuraxial Lock Tip Glass Syringe
K182765
Top Corporation
General Hospital · 340d
Cleared Jul 28, 2019
Bonus Therapeutics Mixing and Delivery System
K190996
Bonus Therapeutics , Ltd.
Orthopedic · 103d
Cleared Jul 18, 2019
Immucise
K190427
Terumo Corporation
General Hospital · 146d
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 Nov 30, 2017
Graft Delivery, DePuy Synthes
K173385
Micromedics, Inc. (D/B/A Nordson Medical)
General Hospital · 31d
Cleared Nov 09, 2017
DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6 NRFit Plastic LOR Syringe + Accessories
K170900
Intervene Group, Ltd.
General Hospital · 227d
Cleared Nov 08, 2017
MHC Standard and NRFit Tip Syringes
K171131
Mazza Healthcare, LLC
General Hospital · 205d
Cleared Sep 08, 2017
Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml
K171805
Conceptomed AS
General Hospital · 81d
Cleared Aug 07, 2017
Merit Syringe
K171362
Merit Medical Systems, Inc.
General Hospital · 90d
Cleared Jul 19, 2017
Graftgun Universal Graft Delivery System
K170675
SurGenTec, LLC
General Hospital · 135d
Cleared Jun 09, 2017
CompuFlo Epidural Computer Controlled Anesthesia System
K161883
Milestone Scientific, Inc.
General Hospital · 333d
Cleared Apr 12, 2017
BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin Syringes with the BD Ultra-Fine™ needle and BD Insulin Syringes with Micro-Fine™ IV Needle
K170386
Becton, Dickinson Company
General Hospital · 63d