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
Apr 20, 2017
Sterile Single-use Infusion Set
Jiangxi Hongda Medical Equipment Group , Ltd.
General Hospital
161d
Cleared
Mar 08, 2017
Burette-type Infusion Sets for Single Use, Disposable Infusion Sets with Precision Filters, Disposable Infusion Set
Beijing Fert Technology Co., Ltd.
General Hospital
240d
Cleared
Mar 08, 2017
Q2 Low Pressure Power Injection Extension Set
Quest Medical, Inc.
General Hospital
154d
Cleared
Jan 06, 2017
Hospira Extension Set, Hospira Primary Set
Hospira, Inc.
General Hospital
268d
Cleared
Dec 19, 2016
Paclitaxel Sets
Baxter Healthcare Corporation
General Hospital
350d
Cleared
Dec 06, 2016
Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets
Quest Medical, Inc.
General Hospital
111d
Cleared
Nov 30, 2016
Solution Set for Epidural Use
Baxter Healthcare Corporation
General Hospital
203d
Cleared
Aug 25, 2016
LifeFlow Rapid Infusion Device (LifeFlow Device)
410 Medical Innovation, LLC
General Hospital
241d
Cleared
Aug 18, 2016
PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set
C.R. Bard, Inc.
General Hospital
265d
Cleared
Aug 10, 2016
MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®
Unomedical A/S
General Hospital
156d
Cleared
Jun 07, 2016
Smart Set
Top Spins, Inc.
General Hospital
392d
Cleared
Jun 01, 2016
Hospira Administration Sets
Hospira, Inc.
General Hospital
63d
Cleared
Apr 12, 2016
Orbit Infusion Set
Ypsomed AG
General Hospital
372d
Cleared
Apr 07, 2016
BD FlowSmart Set, MiniMed Pro-Set
Becton, Dickinson and Company
General Hospital
30d
Cleared
Apr 06, 2016
Extension Set
B.Braun Medical, Inc.
General Hospital
145d
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 14, 2015
Disposable Infusion Needle, Safelock Disposable Infusion Needle
Jiangyin Caina Technology Co., Ltd.
General Hospital
119d
Cleared
Dec 11, 2015
Safelock Disposable Blood Collection Set, Disposable Blood Collection Set
Jiangyin Caina Technology Co., Ltd.
General Hospital
144d
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
Sep 24, 2015
U & U Intravascular Administration Set
U&U Medical Technology Co, Ltd.
General Hospital
147d
Cleared
Aug 13, 2015
Accu-Chek FlexLink Plus infusion set
Roche Diagnostics GmbH
General Hospital
254d
Cleared
Jul 24, 2015
IV Administration Sets with 200(micro)m Blood Filter
B.Braun Medical, Inc.
General Hospital
270d