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
385–408 of 756
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 Nov 06, 1992
PRIMARY SURGICAL DRESSING TRAY
K922041
Transidyne General Corp.
General Hospital · 189d
Cleared Oct 23, 1992
LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER
K922190
Advanced Surgical, Inc.
General Hospital · 165d
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 Jun 26, 1990
DISPOSABLE CORONARY CONTROL SYRINGE
K902346
Advance Medical Designs, Inc.
General Hospital · 32d
Cleared Feb 16, 1990
AUTOPEN
K895890
Ulster Scientific, Inc.
General Hospital · 134d
Cleared Oct 27, 1989
INTOPO
K894206
Acacia, Inc.
General Hospital · 130d
Cleared Sep 19, 1989
30-CS01, 30-CS02, 30-CS03 CONTROL SYRINGES
K894801
Advance Medical Designs, Inc.
General Hospital · 53d
Cleared Sep 12, 1989
NEEDLE*LESS DRUG VIAL ADAPTER
K894177
Baxter Healthcare Corp
General Hospital · 89d
Cleared Sep 12, 1989
SYRINGE TIP ADAPTOR
K894217
Acacia, Inc.
General Hospital · 85d
Cleared Sep 12, 1989
MODEL #535 PACU STRETCHER/BED & #530 ED/TRAUMA STR
K894335
Midmark Corp.
General Hospital · 60d
Cleared Jan 31, 1989
DISPENSING PIN/CHEMOTHERAPY DISPENSING PIN
K890082
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 21d
Cleared Dec 12, 1988
CONTROL SYRINGE
K884497
Professional Medical Services
General Hospital · 48d
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 Sep 09, 1988
OPHTHALMIC PAO VALVE
K882536
Look, Inc.
General Hospital · 80d