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
Jul 21, 2023
BD Alaris™ Pump Infusion Sets
Care Fusion
General Hospital
441d
Cleared
Jun 23, 2023
Surflo Winged Infusion Set
Terumo Medical Products Hangzhou Co., Ltd.
General Hospital
403d
Cleared
Jun 16, 2023
Volumat Polyethylene I.V. Administration Set
Fresenius Kabi
General Hospital
424d
Cleared
Jun 09, 2023
DJF Intravascular Administration Set
Yangzhou Wei DE LI Trade Co., Ltd.
General Hospital
64d
Cleared
Jun 02, 2023
Volumat Line
Fresenius Kabi
General Hospital
485d
Cleared
May 18, 2023
I.V. Administration Set, I.V. Extension Set
Bq Plus Medical Co., Ltd.
General Hospital
163d
Cleared
May 12, 2023
BD Secondary Infusion Set
Care Fusion
General Hospital
224d
Cleared
Apr 19, 2023
NP Medical nPulse K150 Neutral Displacement Needle Free Connector, nPulse Neutral displacement needle free connector, nPulse K150 Needle Free Connector
Np Medical, Inc.
General Hospital
442d
Cleared
Apr 12, 2023
Polyfusion IV Administration Sets
Poly Medicure Limited
General Hospital
434d
Cleared
Apr 07, 2023
BD SmartSite™ Needle-Free Connector
Care Fusion
General Hospital
189d
Cleared
Jan 20, 2023
FlowArt® Needle-Free Split Septum Valve
Asset Medikal Tasarim San Tic As.
General Hospital
119d
Cleared
Nov 21, 2022
Infusion Sets for Single Use with Needles
Sichuan Prius Biotechnology Co., Ltd.
General Hospital
223d
Cleared
Nov 21, 2022
Infusion Sets for Single Use
Sichuan Prius Biotechnology Co., Ltd.
General Hospital
223d
Cleared
Nov 21, 2022
Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use
Sichuan Prius Biotechnology Co., Ltd.
General Hospital
223d
Cleared
Nov 03, 2022
NP Medical nCompass Extension Set with Stabilizing Base
Np Medical
General Hospital
162d
Cleared
Oct 07, 2022
AMSafe NeuFlo Needleless Connector
Amsino International, Inc.
General Hospital
249d
Cleared
Oct 03, 2022
PCA Syringe Sets
Baxter Healthcare Corporation
General Hospital
440d
Cleared
Sep 26, 2022
Flowart
Asset Medikal Tasarim As.
General Hospital
129d
Cleared
Sep 23, 2022
NeutrArt
Asset Medikal Tasarim As.
General Hospital
123d
Cleared
Jun 05, 2022
Q2 Blood Administration Sets
Quest Medical, Inc.
General Hospital
177d
Cleared
Jun 02, 2022
Q2 IV Administration Sets
Quest Medical, Inc.
General Hospital
202d
Cleared
May 10, 2022
Needle Free Connector
Medcaptain Life Science Co., Ltd.
General Hospital
232d
Cleared
Mar 25, 2022
Infusion Sets for Single Use
Jiangsu Suyun Medical Materials Co., Ltd.
General Hospital
577d
Cleared
Mar 03, 2022
IV Administration Set
B.Braun Medical, Inc.
General Hospital
90d