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 Apr 20, 2017
Sterile Single-use Infusion Set
K163160
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
K161898
Beijing Fert Technology Co., Ltd.
General Hospital · 240d
Cleared Mar 08, 2017
Q2 Low Pressure Power Injection Extension Set
K162804
Quest Medical, Inc.
General Hospital · 154d
Cleared Jan 06, 2017
Hospira Extension Set, Hospira Primary Set
K161036
Hospira, Inc.
General Hospital · 268d
Cleared Dec 19, 2016
Paclitaxel Sets
K160007
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
K162304
Quest Medical, Inc.
General Hospital · 111d
Cleared Nov 30, 2016
Solution Set for Epidural Use
K161323
Baxter Healthcare Corporation
General Hospital · 203d
Cleared Aug 25, 2016
LifeFlow Rapid Infusion Device (LifeFlow Device)
K153731
410 Medical Innovation, LLC
General Hospital · 241d
Cleared Aug 18, 2016
PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set
K153440
C.R. Bard, Inc.
General Hospital · 265d
Cleared Aug 10, 2016
MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®
K160648
Unomedical A/S
General Hospital · 156d
Cleared Jun 07, 2016
Smart Set
K151250
Top Spins, Inc.
General Hospital · 392d
Cleared Jun 01, 2016
Hospira Administration Sets
K160870
Hospira, Inc.
General Hospital · 63d
Cleared Apr 12, 2016
Orbit Infusion Set
K150921
Ypsomed AG
General Hospital · 372d
Cleared Apr 07, 2016
BD FlowSmart Set, MiniMed Pro-Set
K160651
Becton, Dickinson and Company
General Hospital · 30d
Cleared Apr 06, 2016
Extension Set
K153293
B.Braun Medical, Inc.
General Hospital · 145d
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 14, 2015
Disposable Infusion Needle, Safelock Disposable Infusion Needle
K152323
Jiangyin Caina Technology Co., Ltd.
General Hospital · 119d
Cleared Dec 11, 2015
Safelock Disposable Blood Collection Set, Disposable Blood Collection Set
K151991
Jiangyin Caina Technology Co., Ltd.
General Hospital · 144d
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 Sep 24, 2015
U & U Intravascular Administration Set
K151151
U&U Medical Technology Co, Ltd.
General Hospital · 147d
Cleared Aug 13, 2015
Accu-Chek FlexLink Plus infusion set
K143446
Roche Diagnostics GmbH
General Hospital · 254d
Cleared Jul 24, 2015
IV Administration Sets with 200(micro)m Blood Filter
K143082
B.Braun Medical, Inc.
General Hospital · 270d