FPA · Class II · 21 CFR 880.5440

FDA Product Code FPA: Set, Administration, Intravascular

Intravenous administration sets are among the most fundamental devices in hospital care. FDA product code FPA covers intravascular administration sets used to deliver fluids, medications, and blood products.

These sets consist of tubing, drip chambers, flow regulators, and connectors that link IV bags or bottles to the patient's vascular access device. They are used across virtually every clinical setting, from emergency departments to intensive care units.

FPA devices are Class II medical devices, regulated under 21 CFR 880.5440 and reviewed by the FDA General Hospital panel.

Leading manufacturers include Baxter Healthcare Corp, Abbott Laboratories and Y.

1176
Total
1176
Cleared
117d
Avg days
1976
Since
1176 devices
289–312 of 1176
Cleared Apr 25, 2002
SIMPLICITY EASY ACCESS II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE
K021005
Sterling Medivations, Inc.
General Hospital · 28d
Cleared Apr 16, 2002
BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100
K013621
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital · 162d
Cleared Apr 10, 2002
SIMPLICITY EASY SOFT INFUSION SET
K020912
Sterling Medivations, Inc.
General Hospital · 21d
Cleared Apr 10, 2002
SIMPLICITY SOFT QD II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE OF THE SKIN
K020990
Sterling Medivations, Inc.
General Hospital · 14d
Cleared Apr 01, 2002
SIMPLICITY SIMPLEX SOFT INFUSION SET
K020629
Sterling Medivations, Inc.
General Hospital · 34d
Cleared Mar 29, 2002
LIFEGUARD SAFETY INFUSION SET
K013871
Horizon Medical Products, Inc.
General Hospital · 128d
Cleared Jan 17, 2002
SIMPLICITY STARPLUS SOFT INFUSION SET
K014061
Sterling Medivations, Inc.
General Hospital · 38d
Cleared Jan 17, 2002
SIMPLICITY EASY ACCESS INFUSION SET
K014062
Sterling Medivations, Inc.
General Hospital · 38d
Cleared Dec 03, 2001
SIMPLICITY CLASSIC WING QD INFUSION SET
K013502
Sterling Medivations, Inc.
General Hospital · 42d
Cleared Oct 15, 2001
SURSHIELD SAFETY WINGED BLOOD COLLECTION SET
K013164
Terumo Medical Corp.
General Hospital · 24d
Cleared Oct 02, 2001
SIMPLICITY QD SOFT INFUSION SET FOR USE BY PEOPLE WITH DIABETES IN INFUSE INSULIN SUBCUTANEOUSLY FROM A PUMP OR SYRINGE
K013104
Sterling Medivations, Inc.
General Hospital · 15d
Cleared Sep 14, 2001
SIMPLICITY SOFT QD MICRO INFUSION SET
K012845
Sterling Medivations, Inc.
General Hospital · 22d
Cleared Aug 10, 2001
HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-05
K011928
Northgate Technologies, Inc.
General Hospital · 51d
Cleared Aug 10, 2001
SIMPLICITY EURO QD INFUSION SET
K012330
Sterling Medivations, Inc.
General Hospital · 18d
Cleared Jun 19, 2001
SIMPLICITY SOFT YP INFUSION SET FOR USE WITH THE MINIMED PARAGIGM INFUSION PUMPS
K011187
Sterling Medivations, Inc.
General Hospital · 62d
Cleared Jun 05, 2001
SIMPLICITY SOFT QD SILVER INFUSION SET
K011580
Sterling Medivations, Inc.
General Hospital · 14d
Cleared May 29, 2001
MEDISYSTEMS LUER ACCESS INJECTION SITE
K010279
Medisystems Corp.
General Hospital · 119d
Cleared Apr 30, 2001
SIMPLICITY WING INFUSION SET
K010886
Sterling Medivations, Inc.
General Hospital · 38d
Cleared Apr 20, 2001
SIMPLICITY SOFT QD EASY INFUSION SET
K010788
Sterling Medivations, Inc.
General Hospital · 36d
Cleared Apr 18, 2001
SIMPLICITY WINGED QD INFUSION SET
K010676
Sterling Medivations, Inc.
General Hospital · 43d
Cleared Apr 13, 2001
SIMPLICITY INFUSER INFUSION SET
K010647
Sterling Medivations, Inc.
General Hospital · 39d
Cleared Apr 12, 2001
SIMPLICITY SILVER SET SOFT INFUSION
K010846
Sterling Medivations, Inc.
General Hospital · 22d
Cleared Mar 15, 2001
SURSHIELD WINGED INFUSION SET
K010103
Terumo Medical Corp.
General Hospital · 62d
Cleared Mar 13, 2001
SIMPLICITY SOFT Y INFUSION SET FOR USE WITH THE MINIMED INFUSION PUMPS AND MINIMED MEDICATION RESERVOIRS (MODEL MMT-103)
K010373
Sterling Medivations, Inc.
General Hospital · 34d