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 Corporation, B.Braun Medical, Inc. and Quest Medical, Inc..
1174
Total
1174
Cleared
117d
Avg days
1976
Since
1174 devices
Cleared
Oct 03, 2022
PCA Syringe Sets
Baxter Healthcare Corporation
General Hospital
440d
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
Mar 03, 2022
IV Administration Set
B.Braun Medical, Inc.
General Hospital
90d
Cleared
Jan 18, 2022
Microvolume Luer Access Device
B.Braun Medical, Inc.
General Hospital
133d
Cleared
Sep 30, 2021
Intravascular Administration Sets
Baxter Healthcare Corporation
General Hospital
294d
Cleared
Sep 24, 2021
IV Administration Sets
B.Braun Medical, Inc.
General Hospital
379d
Cleared
Jun 18, 2021
Intravascular Extension Set
Baxter Healthcare Corporation
General Hospital
126d
Cleared
May 17, 2021
Needleless Connector
Jiangsu Caina Medical Co.,Ltd
General Hospital
110d
Cleared
Mar 24, 2021
Safety Subcutaneous Infusion Set
Epic Medical Pte. , Ltd.
General Hospital
281d
Cleared
Jan 21, 2021
Precision Delivery Infusion Set
Quest Medical, Inc.
General Hospital
128d