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 B.Braun Medical, Inc..
1176
Total
1176
Cleared
117d
Avg days
1976
Since
1176 devices
Cleared
Dec 13, 2019
neria guard Infusion Set
Unomedical A/S
General Hospital
80d
Cleared
May 28, 2019
Clearlink System Solution Set
Baxter Healthcare Corporation
General Hospital
432d
Cleared
May 02, 2019
K-Shield Advantage Port Access Infusion Set (PAIS)
Kawasumi Laboratories, Inc.
General Hospital
85d
Cleared
Apr 04, 2019
HIgH-Flo Super26 Subcutaneous Needle Sets
Repro-Med Systems, Inc. Dba Rms Medical Products
General Hospital
367d
Cleared
Mar 26, 2019
Velano Vascular Q2 Extension Set
Velano Vascular
General Hospital
161d
Cleared
Feb 26, 2019
Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use
Wuhan W.E.O Science & Technology Development Co., Ltd.
General Hospital
229d
Cleared
Jan 11, 2019
Tamper Evident Cap with Male Luer Lock
International Medical Industries, Inc.
General Hospital
116d
Cleared
Oct 18, 2018
BD FlowSmart Set/MiniMed Pro-Set
Becton, Dickinson and Company
General Hospital
111d
Cleared
Sep 05, 2018
AMSafe Sure-Lok Needle-Free Connector
Amsino International, Inc.
General Hospital
280d
Cleared
Jun 26, 2018
IV Administration Set
B.Braun Medical, Inc.
General Hospital
243d
Cleared
Mar 05, 2018
MiniMed Mio Advance infusion set
Unomedical A/S
General Hospital
74d
Cleared
Nov 07, 2017
IV Administration Sets
B.Braun Medical, Inc.
General Hospital
252d
Cleared
Sep 19, 2017
Medline Blood Collection Set
Medline Industries, Inc.
General Hospital
259d
Cleared
Aug 18, 2016
PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set
C.R. Bard, Inc.
General Hospital
265d
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
Jun 29, 2012
FLOWEASE [SUBCUTANEOUS] INFUSION SET
Baxter Healthcare Corp
General Hospital
80d
Cleared
Jul 21, 2011
INFUSION SET FOR POWERPICC SOLO 2 CATHETER
C.R. Bard, Inc.
General Hospital
331d
Cleared
Mar 25, 2011
INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE COATING NON-DEHP CATHETER EXTENSION SET KITS,
Baxter Healthcare Corp
General Hospital
113d
Cleared
Aug 27, 2010
ACCU-CHEK ULTRFLEX INFUSION SET
Roche Diagnostics Corp.
General Hospital
120d
Cleared
Jun 22, 2010
DUAL LUER LOCK CAP, MODEL 2C6250
Baxter Healthcare Corp
General Hospital
35d
Cleared
Apr 21, 2009
INTRAVENOUS POWER INJECTOR EXTENSION SET
C.R. Bard, Inc.
General Hospital
90d
Cleared
Aug 28, 2008
POWERLOC CLEAR SAFETY INFUSION SET
C.R. Bard, Inc.
General Hospital
15d