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, Becton, Dickinson and Company and Promisemed Hangzhou Meditech Co., Ltd..

750
Total
750
Cleared
124d
Avg days
1976
Since
750 devices
145–168 of 750
Cleared Jun 24, 2002
DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML
K020666
Baxter Healthcare Corp
General Hospital · 115d
Cleared Jun 07, 2002
DUPLOREACH
K014088
Baxter Healthcare Corp
General Hospital · 177d
Cleared Jan 08, 2001
STERILE PISTON SYRINGE
K002717
Abbott Laboratories
General Hospital · 130d
Cleared Nov 07, 2000
DUPLOGRIP
K003193
Baxter Healthcare Corp
General Hospital · 26d
Cleared Jul 05, 2000
TISSOMAT AND SPRAY SET
K981089
Baxter Healthcare Corp
General Hospital · 833d
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 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 Apr 02, 1998
B-D E ML PEN
K980755
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 36d
Cleared Nov 21, 1995
BECTON DICKINSON SYRINGSE
K954064
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 83d
Cleared Oct 24, 1995
B-D PEN ULTRA
K951919
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 183d
Cleared Jul 21, 1994
SYRINGE
K942615
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 49d
Cleared Jun 17, 1994
MEDSAVER SYRINGE
K941095
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 100d
Cleared May 26, 1994
1ML LUER-LOK SYRINGE
K941562
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 55d
Cleared May 26, 1994
BD MICRO FINE, ULTRA FINE, AND ALLERGY SYRINGE
K941657
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 51d
Cleared May 23, 1994
ADVANTAGE SYRINGE
K941545
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 54d
Cleared May 17, 1993
BECTON DICKINSON DISPOS. SYRINGES PLUNGER TIP MOD.
K930321
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 115d
Cleared Apr 07, 1993
BECTON DICKINSON ARTERIAL BLOOD GAS KITS
K930342
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 72d
Cleared Dec 17, 1992
BECTON DICKINSON SAFETY-LOK SYRINGE
K924072
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 127d
Cleared Jul 13, 1992
IRRIGATING SYRINGE
K912437
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 406d
Cleared Apr 29, 1992
B-D INTERLINK SYRINGE CANNULA
K920422
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 89d
Cleared Apr 20, 1992
BECTON DICKINSON SAFETY-LOK SYRINGE
K920321
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 87d
Cleared Oct 11, 1991
B-D(TM) MICROFINE(TM) IV PEN INJECTOR CAT. #328204
K912330
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 140d