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 Y.

1176
Total
1176
Cleared
117d
Avg days
1976
Since
1176 devices
73–96 of 1176
Cleared Dec 13, 2019
neria guard Infusion Set
K192647
Unomedical A/S
General Hospital · 80d
Cleared May 28, 2019
Clearlink System Solution Set
K180739
Baxter Healthcare Corporation
General Hospital · 432d
Cleared May 02, 2019
K-Shield Advantage Port Access Infusion Set (PAIS)
K190233
Kawasumi Laboratories, Inc.
General Hospital · 85d
Cleared Apr 04, 2019
HIgH-Flo Super26 Subcutaneous Needle Sets
K180843
Repro-Med Systems, Inc. Dba Rms Medical Products
General Hospital · 367d
Cleared Mar 26, 2019
Velano Vascular Q2 Extension Set
K182897
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
K181870
Wuhan W.E.O Science & Technology Development Co., Ltd.
General Hospital · 229d
Cleared Jan 11, 2019
Tamper Evident Cap with Male Luer Lock
K182545
International Medical Industries, Inc.
General Hospital · 116d
Cleared Oct 18, 2018
BD FlowSmart Set/MiniMed Pro-Set
K181718
Becton, Dickinson and Company
General Hospital · 111d
Cleared Sep 05, 2018
AMSafe Sure-Lok Needle-Free Connector
K173665
Amsino International, Inc.
General Hospital · 280d
Cleared Jun 26, 2018
IV Administration Set
K173361
B.Braun Medical, Inc.
General Hospital · 243d
Cleared Mar 05, 2018
MiniMed Mio Advance infusion set
K173879
Unomedical A/S
General Hospital · 74d
Cleared Nov 07, 2017
IV Administration Sets
K170595
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
K162812
Unomedical A/S
General Hospital · 391d
Cleared Sep 22, 2017
IV Fat Emulsion Administration Sets
K172544
Baxter Healthcare Corporation
General Hospital · 30d
Cleared Sep 19, 2017
Medline Blood Collection Set
K170002
Medline Industries, Inc.
General Hospital · 259d
Cleared Sep 01, 2017
Carefusion NeutraClear Needle-free connector (EL-NC1000)
K171117
Cair Lgl
General Hospital · 140d
Cleared Aug 15, 2017
Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s)
K171118
Cair Lgl
General Hospital · 123d
Cleared Jul 31, 2017
Carefusion NeutraClear Needle-free connector
K171132
Cair Lgl
General Hospital · 105d
Cleared Jul 28, 2017
TUBETECH IV Administration Set
K162951
Douglas Medical Products, Inc.
General Hospital · 277d
Cleared Jul 19, 2017
MaxZero Extension Sets with Needless Connector
K171957
Carefusion 303, Inc.
General Hospital · 20d
Cleared Jun 21, 2017
Solution Set with 1.2 Micron Air Eliminating Filter
K161808
Baxter Healthcare Corporation
General Hospital · 355d
Cleared Jun 15, 2017
Encore Neutral
K162826
Rymed Technologies, LLC
General Hospital · 251d
Cleared Jun 02, 2017
Closed Male Luer
K171101
Yukon Medical
General Hospital · 50d
Cleared May 31, 2017
Infusion Set for Single Use
K162601
Shinva Ande Healthcare Apparatus Co., Ltd.
General Hospital · 254d