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
Cleared
Jan 19, 2016
Hospira Extension Sets
Icu Medical, Inc.
General Hospital
187d
Cleared
Dec 28, 2015
Solution Administration Sets with 0.2 Micron Filter
Baxter Healthcare Corporation
General Hospital
56d
Cleared
Dec 11, 2015
BD FlowSmart Set, MiniMed Pro-Set
Becton, Dickinson and Company
General Hospital
31d
Cleared
Sep 30, 2015
Q2 Intravenous Adminstration Sets and Extension Sets
Quest Medical, Inc.
General Hospital
161d
Cleared
Jul 24, 2015
IV Administration Sets with 200(micro)m Blood Filter
B.Braun Medical, Inc.
General Hospital
270d
Cleared
Apr 16, 2015
Nitroglycerin Sets with DUO-VENT Spike
Baxter Healthcare Corporation
General Hospital
15d
Cleared
Mar 04, 2015
Hospira Blood Set
Hospira, Inc.
General Hospital
128d
Cleared
Feb 25, 2015
Hospira Primary Sets
Hospira, Inc.
General Hospital
128d
Cleared
Jan 15, 2015
IV Administration
Hospira, Inc.
General Hospital
121d
Cleared
Jan 09, 2015
Extension Sets
Hospira, Inc.
General Hospital
87d
Cleared
Dec 08, 2014
Hospira Extension Set
Hospira, Inc.
General Hospital
101d
Cleared
Dec 05, 2014
IV ADMINISTRATION SET WITH HAND PUMP
B.Braun Medical, Inc.
General Hospital
247d
Cleared
Nov 25, 2014
Hospira Primary Sets
Hospira, Inc.
General Hospital
92d
Cleared
Aug 25, 2014
INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETS
B.Braun Medical, Inc.
General Hospital
28d
Cleared
Aug 18, 2014
SOLUTION SET/EXTENSION SET
Baxter Healthcare Corporation
General Hospital
25d
Cleared
May 07, 2014
CARESITE LUER ACCESS DEVICE
B.Braun Medical, Inc.
General Hospital
89d
Cleared
Jan 08, 2014
MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLE
Medical Components, Inc.
General Hospital
117d
Cleared
Oct 08, 2013
NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS
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
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
Baxter Healthcare Corp
General Hospital
22d
Cleared
Oct 18, 2012
NIPRO HUBER INFUSION SET, EXCEL HUBER INFUSION SET
Nipro Medical Corporation
General Hospital
331d
Cleared
Oct 17, 2012
NIPRO SAFE TOUCH HUBER INFUSION SET
Nipro Medical Corporation
General Hospital
330d
Cleared
Jun 29, 2012
FLOWEASE [SUBCUTANEOUS] INFUSION SET
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
Baxter Healthcare Corporation
General Hospital
25d