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 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 Jun 21, 2017
Solution Set with 1.2 Micron Air Eliminating Filter
K161808
Baxter Healthcare Corporation
General Hospital · 355d
Cleared Mar 08, 2017
Q2 Low Pressure Power Injection Extension Set
K162804
Quest Medical, Inc.
General Hospital · 154d
Cleared Jan 06, 2017
Hospira Extension Set, Hospira Primary Set
K161036
Hospira, Inc.
General Hospital · 268d
Cleared Dec 19, 2016
Paclitaxel Sets
K160007
Baxter Healthcare Corporation
General Hospital · 350d
Cleared Dec 06, 2016
Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets
K162304
Quest Medical, Inc.
General Hospital · 111d
Cleared Nov 30, 2016
Solution Set for Epidural Use
K161323
Baxter Healthcare Corporation
General Hospital · 203d
Cleared Aug 18, 2016
PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set
K153440
C.R. Bard, Inc.
General Hospital · 265d
Cleared Jun 01, 2016
Hospira Administration Sets
K160870
Hospira, Inc.
General Hospital · 63d
Cleared Apr 07, 2016
BD FlowSmart Set, MiniMed Pro-Set
K160651
Becton, Dickinson and Company
General Hospital · 30d
Cleared Apr 06, 2016
Extension Set
K153293
B.Braun Medical, Inc.
General Hospital · 145d