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
649–672 of 1176
Cleared Jan 09, 1986
CHURCHILL-HCM VENTED IV SET
K854628
Churchill Corp.
General Hospital · 52d
Cleared Dec 10, 1985
CHURCHILL-HS SUSPENDED VENTED IV SET
K854627
Churchill Corp.
General Hospital · 22d
Cleared Dec 10, 1985
CHURCHILL-HS SUSPENDED NON-VENTED IV SET
K854630
Churchill Corp.
General Hospital · 22d
Cleared Dec 10, 1985
CHURCHILL-HE VENTED IV SET
K854636
Churchill Corp.
General Hospital · 21d
Cleared Dec 05, 1985
CHURCHILL-H NON-VENTED IV SET
K854435
Churchill Corp.
General Hospital · 30d
Cleared Dec 05, 1985
CHURCHILL-H SCALP VEIN SET
K854436
Churchill Corp.
General Hospital · 30d
Cleared Dec 05, 1985
CHURCHILL-H VENTED IV SET
K854437
Churchill Corp.
General Hospital · 30d
Cleared Oct 17, 1985
HUBOUT
K853287
I M, Inc.
General Hospital · 73d
Cleared Sep 05, 1985
CHURCHILL VENTED IV SET
K853204
Churchill Corp.
General Hospital · 37d
Cleared Jun 27, 1985
CONTROLLED RELEASE INFUSION SYSTEM(CRIS)
K852488
Y
General Hospital · 20d
Cleared May 30, 1985
NAMIC CONTRAST & FLUID DELIVERY SPIKES(VARIOUS)
K852140
North American Instrument Corp.
General Hospital · 14d
Cleared May 07, 1985
CORRECT FLO
K851299
Norton Performance Plastics Corp.
General Hospital · 36d
Cleared Apr 09, 1985
IVAC DRUG ADMINISTRATION DEVICE
K844843
Y
General Hospital · 117d
Cleared Mar 27, 1985
MICRO VOLUME DOUBLE LINE EXTENSION SET
K850061
Travenol Laboratories, S.A.
General Hospital · 78d
Cleared Mar 07, 1985
CRITIKON I.V. ADMINISTRAION SET
K850507
Critikon Company, LLC
General Hospital · 27d
Cleared Jan 25, 1985
IVAC 52-99-0 UNVENTED & 52-99-1 VENTED VOL. INFUSI
K844937
Y
General Hospital · 37d
Cleared Jan 03, 1985
ANTI-ASPIRATION VALVE
K843748
Travenol Laboratories, S.A.
General Hospital · 100d
Cleared Oct 19, 1984
MINISET VEIN INFUSION SETS
K843631
Travenol Laboratories, S.A.
General Hospital · 32d
Cleared Oct 16, 1984
EXTENSION SET W/INJECTION SITE
K842984
Med Fusion Systems, Inc.
General Hospital · 78d
Cleared Sep 20, 1984
IVAC C80014 Y SOLUTION ADMIN. SET
K843185
Y
General Hospital · 38d
Cleared Sep 11, 1984
FLUID ADMINISTRATION LINE W/SPIKE 14-923
K842858
Norton Performance Plastics Corp.
General Hospital · 50d
Cleared Sep 07, 1984
T-TYPE IV EXTENSION SET
K843249
Strato Medical Corp.
General Hospital · 18d
Cleared Jul 20, 1984
BENT WINGED MINI-VOL INFUSION SET
K842143
Med Fusion Systems, Inc.
General Hospital · 51d
Cleared Jun 05, 1984
THREE WAY INFUSION SET
K841882
Med Fusion Systems, Inc.
General Hospital · 29d