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
169–192 of 756
Cleared Jun 18, 2015
Safety Disposable Insulin Syringe
K150758
Jiangyin Caina Technology Co., Ltd.
General Hospital · 87d
Cleared Jun 05, 2015
HumaPen Luxura
K142518
Eli Lilly and Company
General Hospital · 270d
Cleared Apr 23, 2015
ConMed Mixing and Delivery Kit
K142535
Conmed Corporation
General Hospital · 226d
Cleared Jan 08, 2015
ANUTRA Feedback Aspiration Syringe
K143757
Anutra Medical, Inc.
General Hospital · 8d
Cleared Dec 17, 2014
InFill Graft Delivery System
K143488
Pinnacle Spine Group, LLC
General Hospital · 9d
Cleared Dec 11, 2014
Bi-Portal Bone Graft Delivery Device
K142661
Spinal Surgical Strategies, LLC
General Hospital · 84d
Cleared Oct 17, 2014
Merit 10mL Syringe
K142636
Merit Medical Systems, Inc.
General Hospital · 30d
Cleared Sep 04, 2014
BIOMET GRAFT DELIVERY SYRINGES
K140710
Biomet Spine (Aka Ebi, LLC)
General Hospital · 167d
Cleared Aug 27, 2014
PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEM
K141762
Biomet, Inc.
General Hospital · 57d
Cleared Jul 25, 2014
HARD PACK SYRINGE
K141359
Jiangyin Caina Technology Co., Ltd.
General Hospital · 63d
Cleared Jul 09, 2014
ETEX MIXING AND DELIVERY SYSTEM
K141245
Etex Corporation
General Hospital · 56d
Cleared Apr 14, 2014
NAMIC RCS SYRINGE
K140194
Navilyst Medical, Inc.
General Hospital · 77d
Cleared Mar 27, 2014
SINGLE USE STERILE SYRINGE WITH NEEDLE
K133493
Jiangxi Kelun Medical Devices Manufacturing Co.,Lt
General Hospital · 133d
Cleared Mar 21, 2014
APOTECA DUG COMPOUNDING DOSING DEVICE,APOTECA I.V. TRANSFER SET
K132011
Aea Srl
General Hospital · 263d
Cleared Feb 27, 2014
U&U STERILE PISTON SYRINGE WITHOUT NEEDLE
K132553
U&U Medical Technology Co, Ltd.
General Hospital · 197d
Cleared Feb 20, 2014
JMS SYRINGE
K132321
JMS North America Corporation
General Hospital · 210d
Cleared Jan 13, 2014
MIXING SYRINGE SYSTEM
K133021
Zimmer Knee Creations, Inc.
General Hospital · 109d
Cleared Dec 12, 2013
WTF SECURA SYRINGE AND NEEDLE
K132120
Beijing Wantefu Medical Apparatus Co., Ltd.
General Hospital · 156d
Cleared Nov 20, 2013
STERILE PISTON HYPODERMIC SYRINGES (WITH/WITHOUT NEEDLE), HYPODERMIC NEEDLES
K130230
Wuxi Yushou Medical Applicances Co., Ltd.
General Hospital · 295d
Cleared Nov 05, 2013
INFUSION SYRINGE SET
K131661
Innovative Medical Manufacturing Co.
General Hospital · 151d
Cleared Oct 22, 2013
TAUTONA INJECTOR DEVICE
K131963
Tautona Group, LLC
General Hospital · 117d
Cleared Sep 12, 2013
JUNG RIM SINGLE USE HYPODERMIC SYRINGE WITH NEEDLE
K124037
Jung Rim Medical Industrial Co., Ltd.
General Hospital · 258d
Cleared Aug 28, 2013
MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP)
K131641
Nipro Medical Corporation
General Hospital · 85d
Cleared Aug 15, 2013
NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN
K123766
Novo Nordisk, Inc.
General Hospital · 251d