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 B.Braun Medical, Inc..

1176
Total
1176
Cleared
117d
Avg days
1976
Since
1176 devices
25–48 of 1176
Cleared Jul 21, 2023
BD Alaris™ Pump Infusion Sets
K221327
Care Fusion
General Hospital · 441d
Cleared Jun 23, 2023
Surflo Winged Infusion Set
K221411
Terumo Medical Products Hangzhou Co., Ltd.
General Hospital · 403d
Cleared Jun 16, 2023
Volumat Polyethylene I.V. Administration Set
K221121
Fresenius Kabi
General Hospital · 424d
Cleared Jun 09, 2023
DJF Intravascular Administration Set
K230992
Yangzhou Wei DE LI Trade Co., Ltd.
General Hospital · 64d
Cleared Jun 02, 2023
Volumat Line
K220301
Fresenius Kabi
General Hospital · 485d
Cleared May 18, 2023
I.V. Administration Set, I.V. Extension Set
K223645
Bq Plus Medical Co., Ltd.
General Hospital · 163d
Cleared May 12, 2023
BD Secondary Infusion Set
K223101
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
K220288
Np Medical, Inc.
General Hospital · 442d
Cleared Apr 12, 2023
Polyfusion IV Administration Sets
K220312
Poly Medicure Limited
General Hospital · 434d
Cleared Apr 07, 2023
BD SmartSite™ Needle-Free Connector
K223088
Care Fusion
General Hospital · 189d
Cleared Jan 20, 2023
FlowArt® Needle-Free Split Septum Valve
K222889
Asset Medikal Tasarim San Tic As.
General Hospital · 119d
Cleared Nov 21, 2022
Infusion Sets for Single Use with Needles
K221069
Sichuan Prius Biotechnology Co., Ltd.
General Hospital · 223d
Cleared Nov 21, 2022
Infusion Sets for Single Use
K221075
Sichuan Prius Biotechnology Co., Ltd.
General Hospital · 223d
Cleared Nov 21, 2022
Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use
K221078
Sichuan Prius Biotechnology Co., Ltd.
General Hospital · 223d
Cleared Nov 03, 2022
NP Medical nCompass Extension Set with Stabilizing Base
K221518
Np Medical
General Hospital · 162d
Cleared Oct 07, 2022
AMSafe NeuFlo Needleless Connector
K220267
Amsino International, Inc.
General Hospital · 249d
Cleared Oct 03, 2022
PCA Syringe Sets
K212262
Baxter Healthcare Corporation
General Hospital · 440d
Cleared Sep 26, 2022
Flowart
K221473
Asset Medikal Tasarim As.
General Hospital · 129d
Cleared Sep 23, 2022
NeutrArt
K221481
Asset Medikal Tasarim As.
General Hospital · 123d
Cleared Jun 05, 2022
Q2 Blood Administration Sets
K213846
Quest Medical, Inc.
General Hospital · 177d
Cleared Jun 02, 2022
Q2 IV Administration Sets
K213588
Quest Medical, Inc.
General Hospital · 202d
Cleared May 10, 2022
Needle Free Connector
K213004
Medcaptain Life Science Co., Ltd.
General Hospital · 232d
Cleared Mar 25, 2022
Infusion Sets for Single Use
K202437
Jiangsu Suyun Medical Materials Co., Ltd.
General Hospital · 577d
Cleared Mar 03, 2022
IV Administration Set
K213778
B.Braun Medical, Inc.
General Hospital · 90d