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
577–600 of 1176
Cleared Feb 01, 1990
EXTENSION SET
K896561
Westmark, Sterile Packing Systems, Inc. (Sps)
General Hospital · 76d
Cleared Jan 18, 1990
GRIPPER PORT-A-CATH NEEDLE WITH STOPCOCK
K896346
Pharmacia Deltec, Inc.
General Hospital · 76d
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 Dec 01, 1989
BLUNT NEEDLE PORT/I.V. PORT
K895480
Applied Medical Technologies
General Hospital · 81d
Cleared Oct 25, 1989
REMOTE RESERVOIR ADAPTER CASSETTE W/BAG SPIKE
K895046
Pharmacia Deltec, Inc.
General Hospital · 77d
Cleared Sep 19, 1989
MEDI-TRACE ACCU-NATE DEVICE
K891193
Graphic Controls Corp.
General Hospital · 197d
Cleared Sep 18, 1989
VOLUMETRIC PUMP SOLUTION SET FOR FLO-GARD 8000
K893716
Baxter Healthcare Corp
General Hospital · 123d
Cleared Sep 12, 1989
IMED GEMINI 12 NONVENTED Y-TYPE BLOOD/SOLUTION ADM
K894842
Imed Corp.
General Hospital · 43d
Cleared Aug 25, 1989
MODIFIED MATERIAL USED IN INFUSION T
K893909
Quinton, Inc.
General Hospital · 87d
Cleared Jul 24, 1989
KENDALL CURITY INTRAVASCULAR CUT DOWN TUBES
K892438
The Kendal Co.
General Hospital · 105d
Cleared Jul 24, 1989
KENDALL CURITY EXTENSION TUBES
K892440
The Kendal Co.
General Hospital · 105d
Cleared Jun 23, 1989
SURFLO(R) WINGED INFUSION SET
K891063
Terumo Medical Corp.
General Hospital · 114d
Cleared Jun 23, 1989
TERUMO SURFLO(R) INJECTION PLUG
K891146
Terumo Medical Corp.
General Hospital · 112d
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 Feb 24, 1989
CRIS ADAPTER
K883986
Y
General Hospital · 157d
Cleared Jan 31, 1989
MODIFIED 7 INCH CONTINUOUS INFUSION SETS
K884102
Quinton, Inc.
General Hospital · 144d
Cleared Jan 31, 1989
WINGED INFUSION SET
K885264
E-Z-Em, Inc.
General Hospital · 40d
Cleared Jan 24, 1989
STANDARD ADMINISTRATION SETS
K885030
3M Company
General Hospital · 50d
Cleared Oct 21, 1988
VALLEYLAB I.V. ADMINISTRATION SETS
K883318
Valleylab, Inc.
General Hospital · 77d
Cleared Sep 29, 1988
LECTROSPIRAL
K883612
Vygon Corp.
General Hospital · 38d
Cleared Sep 23, 1988
SAFESITE INJECTION SITE AND BLUNT CANNULA
K883638
Baxter Healthcare Corp
General Hospital · 29d