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 Baxter Healthcare Corporation.
1176
Total
1176
Cleared
117d
Avg days
1976
Since
1176 devices
Cleared
Jan 18, 2022
Microvolume Luer Access Device
B.Braun Medical, Inc.
General Hospital
133d
Cleared
Nov 10, 2021
Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector
Ivenix, Inc.
General Hospital
47d
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
Aug 14, 2021
I.V. Administration Set
Bq Plus Medical Co., Ltd.
General Hospital
186d
Cleared
Aug 13, 2021
Insignis Subcutaneous Needle Sets
Innovative Health Sciences, LLC
General Hospital
367d
Cleared
Jul 30, 2021
Firefly Needleless Connector
Puracath Medical, Inc.
General Hospital
214d
Cleared
Jul 16, 2021
Medtronic Extended infusion set
Unomedical A/S
Chemistry
142d
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
Feb 23, 2021
Velano ExT Extension Set
Velano Vascular
General Hospital
365d
Cleared
Jan 21, 2021
Precision Delivery Infusion Set
Quest Medical, Inc.
General Hospital
128d
Cleared
Jan 05, 2021
NeutrArt
Asset Medikal Tasarim As.
General Hospital
182d
Cleared
Oct 29, 2020
Female Luer Lock Cap
Medsafety Solutions, LLC
General Hospital
252d
Cleared
Oct 23, 2020
MaxZero Extension Sets with Needle-Free Connector(s)
Carefusion, Inc.
General Hospital
352d
Cleared
Oct 08, 2020
Steripath Micro Blood Collection System
Magnolia Medical Technologies, Inc.
General Hospital
210d
Cleared
Sep 18, 2020
Intellifuse Administration and Intellifuse Blood Administration Sets
Smiths Medical Asd, Inc.
General Hospital
385d
Cleared
Aug 26, 2020
TK Intravascular Administration Set
Anhui Tiankang Medical Technology Co., Ltd.
General Hospital
434d
Cleared
Jul 28, 2020
Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type)
Jiangsu Kangbao Medical Equipment Co., Ltd.
General Hospital
306d
Cleared
Jul 20, 2020
Intravascular Extension Sets and Accessories
Baxter Healthcare Corporation
General Hospital
325d
Cleared
May 20, 2020
LifeFlow Blood System
410 Medical, Inc.
General Hospital
364d
Cleared
Mar 19, 2020
IV Sets not made with PVC
B.Braun Medical, Inc.
General Hospital
272d
Cleared
Feb 20, 2020
Flowart
Asset Medikal Tasarim As.
General Hospital
328d