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
217–240 of 753
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 Nov 25, 1992
MONOJECT SAFETY SYRINGE, 1 CC, 3CC AND 12 CC SIZES
K922522
Sherwood Medical Co.
General Hospital · 181d
Cleared Sep 30, 1992
VISITEC ASPIRATING SYRINGE
K923645
Visitec Co.
General Hospital · 71d
Cleared Sep 21, 1992
ENDOPATH ENDO-SURGERY PERCUTANEOUS CATHETER INTROD
K921833
Ethicon, Inc.
General Hospital · 158d
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 31, 1991
DAVOL IMPLANT PORTS W/ATTACH HI PERF GROSHONG CATH
K913235
Davol, Inc.
General Hospital · 101d
Cleared Oct 11, 1991
B-D(TM) MICROFINE(TM) IV PEN INJECTOR CAT. #328204
K912330
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 140d
Cleared Nov 29, 1990
JOHNSON & JOHNSON DUAL SYRINGE APPLICATOR
K902157
Johnson & Johnson Medical, Inc.
General Hospital · 198d
Cleared Sep 12, 1989
NEEDLE*LESS DRUG VIAL ADAPTER
K894177
Baxter Healthcare Corp
General Hospital · 89d
Cleared Jan 31, 1989
DISPENSING PIN/CHEMOTHERAPY DISPENSING PIN
K890082
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 21d
Cleared Oct 17, 1988
SINGLE-FIL(TM) SYRINGE
K883955
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 28d
Cleared Sep 28, 1988
MANAN HUBER STYLE INFUSION NEEDLE
K883744
Manan Medical Products, Inc.
General Hospital · 27d
Cleared Aug 23, 1988
BD MICROFINE IV PEN INJECTOR
K881775
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 119d
Cleared Aug 10, 1988
MX350 (SERIES) CONTROL SYRINGE
K883094
Medex, Inc.
General Hospital · 19d
Cleared Jun 24, 1988
HAC AUTOLOGY CENTERS DISPENSING KIT FOR FIB.CON.
K880963
Buckman Co., Inc.
General Hospital · 108d
Cleared Jun 16, 1988
DISPOSABLE SYRINGE
K882335
Baxter Healthcare Corp
General Hospital · 10d
Cleared May 11, 1988
MEDSURG MYELOGRAM TRAY
K880693
Medsurg Industries, Inc.
General Hospital · 79d
Cleared Mar 31, 1988
ALLERGIST SYRINGES
K880894
Abco Dealers, Inc.
General Hospital · 29d
Cleared Sep 04, 1987
SAFETY SYRINGE
K872820
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 50d
Cleared Aug 06, 1987
MONOJECT PHARMACY TRAY
K860688
Sherwood Medical Co.
General Hospital · 527d