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 Y.
1176
Total
1176
Cleared
117d
Avg days
1976
Since
1176 devices
Cleared
Dec 13, 2019
neria guard Infusion Set
Unomedical A/S
General Hospital
80d
Cleared
May 28, 2019
Clearlink System Solution Set
Baxter Healthcare Corporation
General Hospital
432d
Cleared
May 02, 2019
K-Shield Advantage Port Access Infusion Set (PAIS)
Kawasumi Laboratories, Inc.
General Hospital
85d
Cleared
Apr 04, 2019
HIgH-Flo Super26 Subcutaneous Needle Sets
Repro-Med Systems, Inc. Dba Rms Medical Products
General Hospital
367d
Cleared
Mar 26, 2019
Velano Vascular Q2 Extension Set
Velano Vascular
General Hospital
161d
Cleared
Feb 26, 2019
Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use
Wuhan W.E.O Science & Technology Development Co., Ltd.
General Hospital
229d
Cleared
Jan 11, 2019
Tamper Evident Cap with Male Luer Lock
International Medical Industries, Inc.
General Hospital
116d
Cleared
Oct 18, 2018
BD FlowSmart Set/MiniMed Pro-Set
Becton, Dickinson and Company
General Hospital
111d
Cleared
Sep 05, 2018
AMSafe Sure-Lok Needle-Free Connector
Amsino International, Inc.
General Hospital
280d
Cleared
Jun 26, 2018
IV Administration Set
B.Braun Medical, Inc.
General Hospital
243d
Cleared
Mar 05, 2018
MiniMed Mio Advance infusion set
Unomedical A/S
General Hospital
74d
Cleared
Nov 07, 2017
IV Administration Sets
B.Braun Medical, Inc.
General Hospital
252d
Cleared
Nov 01, 2017
Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion Set
Unomedical A/S
General Hospital
391d
Cleared
Sep 22, 2017
IV Fat Emulsion Administration Sets
Baxter Healthcare Corporation
General Hospital
30d
Cleared
Sep 19, 2017
Medline Blood Collection Set
Medline Industries, Inc.
General Hospital
259d
Cleared
Sep 01, 2017
Carefusion NeutraClear Needle-free connector (EL-NC1000)
Cair Lgl
General Hospital
140d
Cleared
Aug 15, 2017
Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s)
Cair Lgl
General Hospital
123d
Cleared
Jul 31, 2017
Carefusion NeutraClear Needle-free connector
Cair Lgl
General Hospital
105d
Cleared
Jul 28, 2017
TUBETECH IV Administration Set
Douglas Medical Products, Inc.
General Hospital
277d
Cleared
Jul 19, 2017
MaxZero Extension Sets with Needless Connector
Carefusion 303, Inc.
General Hospital
20d
Cleared
Jun 21, 2017
Solution Set with 1.2 Micron Air Eliminating Filter
Baxter Healthcare Corporation
General Hospital
355d
Cleared
Jun 15, 2017
Encore Neutral
Rymed Technologies, LLC
General Hospital
251d
Cleared
Jun 02, 2017
Closed Male Luer
Yukon Medical
General Hospital
50d
Cleared
May 31, 2017
Infusion Set for Single Use
Shinva Ande Healthcare Apparatus Co., Ltd.
General Hospital
254d