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 Baxter Healthcare Corporation.

1176
Total
1176
Cleared
117d
Avg days
1976
Since
1176 devices
49–72 of 1176
Cleared Jan 18, 2022
Microvolume Luer Access Device
K212842
B.Braun Medical, Inc.
General Hospital · 133d
Cleared Nov 10, 2021
Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector
K213089
Ivenix, Inc.
General Hospital · 47d
Cleared Sep 30, 2021
Intravascular Administration Sets
K203609
Baxter Healthcare Corporation
General Hospital · 294d
Cleared Sep 24, 2021
IV Administration Sets
K202618
B.Braun Medical, Inc.
General Hospital · 379d
Cleared Aug 14, 2021
I.V. Administration Set
K210381
Bq Plus Medical Co., Ltd.
General Hospital · 186d
Cleared Aug 13, 2021
Insignis Subcutaneous Needle Sets
K202279
Innovative Health Sciences, LLC
General Hospital · 367d
Cleared Jul 30, 2021
Firefly Needleless Connector
K203796
Puracath Medical, Inc.
General Hospital · 214d
Cleared Jul 16, 2021
Medtronic Extended infusion set
K210544
Unomedical A/S
Chemistry · 142d
Cleared Jun 18, 2021
Intravascular Extension Set
K210430
Baxter Healthcare Corporation
General Hospital · 126d
Cleared May 17, 2021
Needleless Connector
K210217
Jiangsu Caina Medical Co.,Ltd
General Hospital · 110d
Cleared Mar 24, 2021
Safety Subcutaneous Infusion Set
K201626
Epic Medical Pte. , Ltd.
General Hospital · 281d
Cleared Feb 23, 2021
Velano ExT Extension Set
K200439
Velano Vascular
General Hospital · 365d
Cleared Jan 21, 2021
Precision Delivery Infusion Set
K202672
Quest Medical, Inc.
General Hospital · 128d
Cleared Jan 05, 2021
NeutrArt
K201872
Asset Medikal Tasarim As.
General Hospital · 182d
Cleared Oct 29, 2020
Female Luer Lock Cap
K200425
Medsafety Solutions, LLC
General Hospital · 252d
Cleared Oct 23, 2020
MaxZero Extension Sets with Needle-Free Connector(s)
K193088
Carefusion, Inc.
General Hospital · 352d
Cleared Oct 08, 2020
Steripath Micro Blood Collection System
K200661
Magnolia Medical Technologies, Inc.
General Hospital · 210d
Cleared Sep 18, 2020
Intellifuse Administration and Intellifuse Blood Administration Sets
K192375
Smiths Medical Asd, Inc.
General Hospital · 385d
Cleared Aug 26, 2020
TK Intravascular Administration Set
K191640
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)
K192681
Jiangsu Kangbao Medical Equipment Co., Ltd.
General Hospital · 306d
Cleared Jul 20, 2020
Intravascular Extension Sets and Accessories
K192366
Baxter Healthcare Corporation
General Hospital · 325d
Cleared May 20, 2020
LifeFlow Blood System
K191362
410 Medical, Inc.
General Hospital · 364d
Cleared Mar 19, 2020
IV Sets not made with PVC
K191658
B.Braun Medical, Inc.
General Hospital · 272d
Cleared Feb 20, 2020
Flowart
K190806
Asset Medikal Tasarim As.
General Hospital · 328d