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 Baxter Healthcare Corporation.

1176
Total
1176
Cleared
117d
Avg days
1976
Since
1176 devices
145–168 of 1176
Cleared Jan 11, 1990
AVI MODEL 2012, 1.2 MICRON FILTER IV ADMINISTRA.
K896161
3M Company
General Hospital · 79d
Cleared Dec 06, 1989
VOLUMETRIC PUMP SOLUTION SET W/INTEGRAL AIRWAY
K893646
Baxter Healthcare Corp
General Hospital · 205d
Cleared Sep 18, 1989
VOLUMETRIC PUMP SOLUTION SET FOR FLO-GARD 8000
K893716
Baxter Healthcare Corp
General Hospital · 123d
Cleared Jun 08, 1989
EXTENSION SET W/FLOW REGULATOR
K890489
Baxter Healthcare Corp
General Hospital · 128d
Cleared May 05, 1989
LOW ADSORPTION ADMINISTRATION SET
K885031
3M Company
General Hospital · 151d
Cleared Feb 28, 1989
MONOPLACE HYPERBARIC EXTENSION SET (L 11055)
K884141
Abbott Laboratories
General Hospital · 151d
Cleared Jan 24, 1989
STANDARD ADMINISTRATION SETS
K885030
3M Company
General Hospital · 50d
Cleared Sep 23, 1988
SAFESITE INJECTION SITE AND BLUNT CANNULA
K883638
Baxter Healthcare Corp
General Hospital · 29d
Cleared Jun 20, 1988
EXTENDED LIFE INJECTION SITE
K882007
Baxter Healthcare Corp
General Hospital · 38d
Cleared Jun 16, 1988
BLOOD/SOLUTION SET W/PRESSURE PUMP
K881321
Baxter Healthcare Corp
General Hospital · 79d
Cleared Jun 13, 1988
VENOVALVE(TM)
K881234
Abbott Laboratories
General Hospital · 84d
Cleared May 26, 1988
CHECK VALVE
K881052
Baxter Healthcare Corp
General Hospital · 76d
Cleared Mar 18, 1988
SECONDARY SOLUTION ADMINISTRATION SET W/SHEATH
K880482
Baxter Healthcare Corp
General Hospital · 42d
Cleared Apr 05, 1984
HARVARD ANTI-REFLUX Y-SET
K840760
C.R. Bard, Inc.
General Hospital · 42d
Cleared Mar 30, 1984
QUIK LOK
K840878
Abbott Laboratories
General Hospital · 32d
Cleared Dec 27, 1983
VENOSET MULTI-MED PIGGYBACK W/IVEX-2
K833740
Abbott Laboratories
General Hospital · 62d
Cleared Dec 22, 1983
VENOSET MULTI MED DUAL RATE PIGGYBACK
K833741
Abbott Laboratories
General Hospital · 57d
Cleared Aug 12, 1983
VENIPUNCTURE VALVE
K832123
Abbott Laboratories
General Hospital · 43d
Cleared Jun 22, 1982
VENOSET DUAL-RATE PIGGYBACK W/IVEX &
K821578
Abbott Laboratories
General Hospital · 25d
Cleared Jun 09, 1982
VENTED NITROGLYCERIN I.V. SET
K821515
Abbott Laboratories
General Hospital · 20d
Cleared Dec 02, 1981
AUTO-SYRINGE SUB-CUTEANEOUS SET
K813194
Baxter Healthcare Corp
General Hospital · 15d
Cleared Aug 20, 1981
INTRAVENOUS ADMINISTRATION SET
K812231
Cordis Corp.
General Hospital · 9d
Cleared Jun 12, 1981
AUTO-SYRINGE MICRO VOLUME EXTENSION SET
K811463
Baxter Healthcare Corp
General Hospital · 17d
Cleared May 29, 1981
VENTED PRIMARY PIGGYBACK VENOSET DUAL
K810239
Abbott Laboratories
General Hospital · 121d