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
313–336 of 756
Cleared Mar 04, 1999
ALLISON MEDICAL INSULIN SYRINGE (AMIS)
K984017
Allison Medical, Inc.
General Hospital · 112d
Cleared Feb 09, 1999
LITE-TOUCH SYRINGE
K983430
Medicore, Inc.
General Hospital · 133d
Cleared Jan 08, 1999
UNIFINE
K983994
Owen Mumford USA, Inc.
General Hospital · 60d
Cleared Dec 21, 1998
OWEN MUMFORD 3ML AUTOPEN
K983974
Owen Mumford USA, Inc.
General Hospital · 42d
Cleared Oct 19, 1998
DISETRONIC PEN
K982966
Disetronic Medical Systems
General Hospital · 55d
Cleared Oct 16, 1998
PENETREASE
K980078
P.T. Panca Pusaka Deli
General Hospital · 281d
Cleared Sep 25, 1998
HUMAPEN AND HUMAPEN ERGO
K982842
Eli Lilly and Co.
General Hospital · 44d
Cleared Aug 07, 1998
LIGHT SABER ASPIRATION NEEDLE
K982018
Minrad, Inc.
General Hospital · 60d
Cleared Jul 15, 1998
STERILE WATER FOR INJECTION PREFILLED SYRING (SWFIPS)
K972728
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 359d
Cleared Jun 25, 1998
BECTON DICKINSON SYRINGES
K980580
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 128d
Cleared Jun 25, 1998
MINRAD DRTS LIGHT SABER SYRINGE
K981140
Minrad, Inc.
General Hospital · 87d
Cleared Jun 12, 1998
B-D PEN ULTRA
K981797
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 22d
Cleared Jun 11, 1998
BECTON DICKINSON SYRINGE
K980987
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 86d
Cleared May 01, 1998
GLASS VAN GLASS SYRINGES
K963364
Myco Medical Supplies, Inc.
General Hospital · 613d
Cleared Apr 02, 1998
TERUMO DISPOSABLE HYPODERMC SYRINGE
K980181
Terumo Medical Corp.
General Hospital · 72d
Cleared Apr 02, 1998
B-D E ML PEN
K980755
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 36d
Cleared Apr 02, 1998
TERUMO ALLERGY SYRINGE
K980796
Terumo Corp.
General Hospital · 31d
Cleared Feb 26, 1998
ULTRASAFE INJECTION SYSTEM MODEL C200 INJECTOR WITH NEEDLE GUARD
K972877
Safety Syringes, Inc.
General Hospital · 206d
Cleared Feb 26, 1998
ULTRASAFE MODEL T200 INJECTOR
K972900
Safety Syringes, Inc.
General Hospital · 204d
Cleared Dec 22, 1997
DAXOR MAX100 SYRINGE (MAX100)
K970419
Daxor Corporation
General Hospital · 321d
Cleared Dec 08, 1997
DUPLOJECT (0.5/1.0 ML, 2.0 ML, 5.0 ML)
K973510
Immuno-U.S., Inc.
General Hospital · 83d
Cleared Oct 30, 1997
ULTRASAFE INJECTION SYSTEM NEEDLE GUARD, MODELS B50,B100L,B150,B225, AND B300
K972878
Safety Syringes, Inc.
General Hospital · 87d
Cleared Sep 08, 1997
BIOSURGICAL, CORP. MULTI CHAMBER SUCTION SYRINGE
K964597
Biosurgical Corp.
General Hospital · 294d
Cleared Jul 25, 1997
RAMY PISTON SYRINGE
K971664
Alshifa Medical Syringes Mfg. Co., Ltd.
General Hospital · 80d