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
697–720 of 1176
Cleared Nov 24, 1982
MACRODOT ADD-I-MED ADMIN. SET
K823347
Imed Corp.
General Hospital · 15d
Cleared Nov 22, 1982
ACCUDOT 380 SECONDARY I.V. SET
K823027
Imed Corp.
General Hospital · 39d
Cleared Nov 03, 1982
INFUS. SETS-9120-50 CM & 9121-100 CM,EXT
K822775
Cardiac Pacemakers, Inc.
General Hospital · 50d
Cleared Oct 15, 1982
MICROFLEX-VENOFLUX
K822836
Exco, Inc.
General Hospital · 24d
Cleared Sep 22, 1982
DISPOSABLE PLASTIC TRANSFUS./INFUS. ASSB
K822354
Valleylab, Inc.
General Hospital · 47d
Cleared Jul 02, 1982
AS 700 SERIES INFUSION PUMP ADMIN.
K821377
Narco Scientific
General Hospital · 53d
Cleared Jul 02, 1982
DESERET E-Z SET INFUSION SET
K821750
Warner-Lambert Co.
General Hospital · 17d
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 Apr 15, 1982
MONOJECT SAF-T-LOCK
K820747
Sherwood Medical Co.
General Hospital · 27d
Cleared Apr 06, 1982
CLIRANS PRIMING SET
K820788
Terumo Medical Corp.
General Hospital · 14d
Cleared Mar 08, 1982
THE INT-STOPPER
K820453
Burron Medical Products, Inc.
General Hospital · 18d
Cleared Feb 18, 1982
INTRAVASCULAR ADMINISTRATION SET
K820278
Y
General Hospital · 16d
Cleared Dec 31, 1981
IN-STOPPER (INJECTION CAP
K813259
Burron Medical Products, Inc.
General Hospital · 41d
Cleared Dec 02, 1981
AUTO-SYRINGE SUB-CUTEANEOUS SET
K813194
Baxter Healthcare Corp
General Hospital · 15d
Cleared Nov 16, 1981
VENOFIX SCALP VEIN SET
K813083
Burron Medical Products, Inc.
General Hospital · 14d
Cleared Oct 02, 1981
QI 1150-1T INFUSION T
K812688
Quinton, Inc.
General Hospital · 10d
Cleared Aug 25, 1981
30-30-2 700 SYRINGE EXTENSION SET
K811885
Y
General Hospital · 55d
Cleared Aug 20, 1981
INTRAVENOUS ADMINISTRATION SET
K812231
Cordis Corp.
General Hospital · 9d
Cleared Jul 10, 1981
I.V. ADMINISTRATION SET
K811837
Medisystems Corp.
General Hospital · 9d
Cleared Jul 02, 1981
RADIATION STERILIZED ADMIN. SET
K811078
Travenol Laboratories, S.A.
General Hospital · 73d
Cleared Jun 30, 1981
I.V. ADMINISTRATION SET
K811685
Quest Medical, Inc.
General Hospital · 15d
Cleared Jun 12, 1981
IV SETS
K811107
Critikon Company, LLC
General Hospital · 50d
Cleared Jun 12, 1981
AUTO-SYRINGE MICRO VOLUME EXTENSION SET
K811463
Baxter Healthcare Corp
General Hospital · 17d