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
97–120 of 1176
Cleared Jan 19, 2016
Hospira Extension Sets
K151969
Icu Medical, Inc.
General Hospital · 187d
Cleared Dec 28, 2015
Solution Administration Sets with 0.2 Micron Filter
K153158
Baxter Healthcare Corporation
General Hospital · 56d
Cleared Dec 11, 2015
BD FlowSmart Set, MiniMed Pro-Set
K153257
Becton, Dickinson and Company
General Hospital · 31d
Cleared Sep 30, 2015
Q2 Intravenous Adminstration Sets and Extension Sets
K151079
Quest Medical, Inc.
General Hospital · 161d
Cleared Jul 24, 2015
IV Administration Sets with 200(micro)m Blood Filter
K143082
B.Braun Medical, Inc.
General Hospital · 270d
Cleared Apr 16, 2015
Nitroglycerin Sets with DUO-VENT Spike
K150860
Baxter Healthcare Corporation
General Hospital · 15d
Cleared Mar 04, 2015
Hospira Blood Set
K143087
Hospira, Inc.
General Hospital · 128d
Cleared Feb 25, 2015
Hospira Primary Sets
K143015
Hospira, Inc.
General Hospital · 128d
Cleared Jan 15, 2015
IV Administration
K142622
Hospira, Inc.
General Hospital · 121d
Cleared Jan 09, 2015
Extension Sets
K142974
Hospira, Inc.
General Hospital · 87d
Cleared Dec 08, 2014
Hospira Extension Set
K142433
Hospira, Inc.
General Hospital · 101d
Cleared Dec 05, 2014
IV ADMINISTRATION SET WITH HAND PUMP
K140838
B.Braun Medical, Inc.
General Hospital · 247d
Cleared Nov 25, 2014
Hospira Primary Sets
K142367
Hospira, Inc.
General Hospital · 92d
Cleared Aug 25, 2014
INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETS
K142036
B.Braun Medical, Inc.
General Hospital · 28d
Cleared Aug 18, 2014
SOLUTION SET/EXTENSION SET
K142011
Baxter Healthcare Corporation
General Hospital · 25d
Cleared May 07, 2014
CARESITE LUER ACCESS DEVICE
K140311
B.Braun Medical, Inc.
General Hospital · 89d
Cleared Jan 08, 2014
MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLE
K132880
Medical Components, Inc.
General Hospital · 117d
Cleared Oct 08, 2013
NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS
K132734
Baxter Healthcare Corp
General Hospital · 35d
Cleared Jan 10, 2013
INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S
K123874
Baxter Healthcare Corp
General Hospital · 24d
Cleared Jan 08, 2013
INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET
K123868
Baxter Healthcare Corp
General Hospital · 22d
Cleared Oct 18, 2012
NIPRO HUBER INFUSION SET, EXCEL HUBER INFUSION SET
K113471
Nipro Medical Corporation
General Hospital · 331d
Cleared Oct 17, 2012
NIPRO SAFE TOUCH HUBER INFUSION SET
K113470
Nipro Medical Corporation
General Hospital · 330d
Cleared Jun 29, 2012
FLOWEASE [SUBCUTANEOUS] INFUSION SET
K121092
Baxter Healthcare Corp
General Hospital · 80d
Cleared Jun 29, 2012
INTERLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATORY CLEARLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATOR
K121634
Baxter Healthcare Corporation
General Hospital · 25d