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
745–768 of 1176
Cleared Apr 30, 1979
T-CONNECTOR
K790408
Medex, Inc.
General Hospital · 63d
Cleared Apr 30, 1979
EPIC D215
K790574
National Patent Development Corp.
General Hospital · 38d
Cleared Apr 10, 1979
IV ADMINISTRATION SET WITH BACKCHECK
K790062
National Patent Development Corp.
General Hospital · 90d
Cleared Mar 06, 1979
FILTERSET 0.22, I.V. PUMP
K790108
Imed Corp.
General Hospital · 49d
Cleared Jan 17, 1979
SOLUTION ADMINISTRATION, TIP PROTECTOR
K781813
Travenol Laboratories, S.A.
General Hospital · 83d
Cleared Jan 17, 1979
FILTER FOR HYPERALIMENTATION SET
K782134
Travenol Laboratories, S.A.
General Hospital · 21d
Cleared Dec 12, 1978
MODEL IV 1500 STANDARD BURETTE
K781637
Valleylab, Inc.
General Hospital · 82d
Cleared Dec 07, 1978
IV SET WITH GRADUATED CHAMBER
K781744
National Patent Development Corp.
General Hospital · 48d
Cleared Dec 07, 1978
SOLUTION ADMINISTRATION, FLEX VALVE
K781812
Travenol Laboratories, S.A.
General Hospital · 42d
Cleared Aug 10, 1978
AUTO-SYRINGE INFUSION SET
K781036
Baxter Healthcare Corp
General Hospital · 52d
Cleared Jul 27, 1978
BURETTE SET WITH AIR CONTROL LEVER
K780970
Travenol Laboratories, S.A.
General Hospital · 45d
Cleared Apr 19, 1978
I.V. ADMINISTRATION SET WITH MINI-SPIKE
K780551
National Patent Development Corp.
General Hospital · 14d
Cleared Apr 10, 1978
I.V. LEVER CLAMP
K780481
Travenol Laboratories, S.A.
General Hospital · 14d
Cleared Feb 21, 1978
BURETTE INTRAVENOUS ADMIN. SETS.
K780130
Y
General Hospital · 28d
Cleared Nov 16, 1977
IN-LINE BURETTE SET
K772036
Abbott Laboratories
Hematology · 20d
Cleared Sep 12, 1977
I.V. PUMP SET FOR FAT EMULSION
K771593
Abbott Laboratories
General Hospital · 24d
Cleared Aug 22, 1977
FLUID HANDLING DEVICE W/INPUT TUBING
K771453
Imed Corp.
General Hospital · 19d
Cleared Jul 14, 1977
SURFLO WINGED INFUSION SET
K771204
Terumo America, Inc.
General Hospital · 9d
Cleared Jun 24, 1977
SOLUSET FOR IV FAT EMULSION
K770743
Abbott Laboratories
General Hospital · 63d
Cleared Jun 08, 1977
BURETTE SET, 2C0132
K770763
Travenol Laboratories, S.A.
General Hospital · 43d
Cleared May 26, 1977
IV SET THAT REVERTS TO KVO RATE
K770744
Abbott Laboratories
General Hospital · 34d
Cleared May 23, 1977
FILTER, INTRAVENOUS W/AUTO AIR VENT
K770589
Jelco Laboratories
General Hospital · 56d
Cleared Apr 29, 1977
PIGGYBACK VENOSET W/0.22 FILTER
K770518
Abbott Laboratories
General Hospital · 42d
Cleared Mar 30, 1977
ERIKA I.V. ADMINISTRATION SET
K770171
Erika, Inc.
General Hospital · 63d