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
673–696 of 1176
Cleared May 21, 1984
SYRINGE ADDITIVE IV ADMIN. SETS
K841361
Quest Medical, Inc.
General Hospital · 49d
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 Mar 06, 1984
LOPEZ LOCK
K840273
Icu Medical, Inc.
General Hospital · 43d
Cleared Feb 21, 1984
NITROGLYCERIN I.V. ADMINISTRATION SET
K833939
Critikon Company, LLC
General Hospital · 98d
Cleared Jan 30, 1984
INTRAVENOUS FILTER SET
K834130
Tri-Med, Inc.
General Hospital · 77d
Cleared Jan 30, 1984
CONTINU-FLO SOLUTION ADMIN. 2C9102
K834289
Travenol Laboratories, S.A.
General Hospital · 53d
Cleared Dec 29, 1983
SOLUTION ADMIN. SET 2C9096 W/10 PVC
K832284
Travenol Laboratories, S.A.
General Hospital · 169d
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 Nov 07, 1983
INFUSION SET-52-05-1 20 DROPS-MI VOL
K833033
Y
General Hospital · 61d
Cleared Nov 07, 1983
UNIVERSAL VENTED & NON/VOLUME INFUS-
K833034
Y
General Hospital · 61d
Cleared Nov 03, 1983
INTRAVASCULAR ADMINISTRATION SET
K833030
Gish Biomedical, Inc.
General Hospital · 57d
Cleared Sep 12, 1983
INFUSION SETS #'S 124 & 142 PERSONAL
K831445
Pacesetter Systems
General Hospital · 130d
Cleared Aug 24, 1983
STERILE IV SET 4 SIZES
K832329
Abco Dealers, Inc.
General Hospital · 40d
Cleared Aug 12, 1983
VENIPUNCTURE VALVE
K832123
Abbott Laboratories
General Hospital · 43d
Cleared Jun 08, 1983
SOLUTION ADMIN. SETS W/FLASHBALL
K831311
Travenol Laboratories, S.A.
General Hospital · 47d
Cleared Apr 14, 1983
SPECIALTY SET MODEL IV7A01
K830891
Valleylab, Inc.
General Hospital · 24d
Cleared Mar 24, 1983
INFUSION PUMP RETROGRADE EXTEN. AS 715
K830654
Narco Scientific
General Hospital · 23d
Cleared Mar 01, 1983
PORT-LOCK
K823845
Norfolk Medical Products, Inc.
General Hospital · 70d
Cleared Feb 09, 1983
MINILOOP I.V. CONNECTORS & ADAPTOR
K830152
Medex, Inc.
General Hospital · 22d
Cleared Feb 07, 1983
MINILOOP DISPOS. IV CONNECTORS ADAPT.
K830178
Medex, Inc.
General Hospital · 20d
Cleared Jan 12, 1983
DOSIMETRIC RELEASE PROGRAM - ADMIN. SET
K823214
Cutter Laboratories, Inc.
Chemistry · 76d
Cleared Nov 30, 1982
ACCUSET ADMINISTRATION SET
K823346
Imed Corp.
General Hospital · 21d