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 B.Braun Medical, Inc..

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 19, 2017
Medline Blood Collection Set
K170002
Medline Industries, Inc.
General Hospital · 259d
Cleared Aug 18, 2016
PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set
K153440
C.R. Bard, Inc.
General Hospital · 265d
Cleared Oct 08, 2013
NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS
K132734
Baxter Healthcare Corp
General Hospital · 35d
Cleared Jan 10, 2013
INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S
K123874
Baxter Healthcare Corp
General Hospital · 24d
Cleared Jan 08, 2013
INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET
K123868
Baxter Healthcare Corp
General Hospital · 22d
Cleared Jun 29, 2012
FLOWEASE [SUBCUTANEOUS] INFUSION SET
K121092
Baxter Healthcare Corp
General Hospital · 80d
Cleared Jul 21, 2011
INFUSION SET FOR POWERPICC SOLO 2 CATHETER
K102405
C.R. Bard, Inc.
General Hospital · 331d
Cleared Mar 25, 2011
INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE COATING NON-DEHP CATHETER EXTENSION SET KITS,
K103551
Baxter Healthcare Corp
General Hospital · 113d
Cleared Aug 27, 2010
ACCU-CHEK ULTRFLEX INFUSION SET
K101196
Roche Diagnostics Corp.
General Hospital · 120d
Cleared Jun 22, 2010
DUAL LUER LOCK CAP, MODEL 2C6250
K101385
Baxter Healthcare Corp
General Hospital · 35d
Cleared Apr 21, 2009
INTRAVENOUS POWER INJECTOR EXTENSION SET
K090134
C.R. Bard, Inc.
General Hospital · 90d
Cleared Aug 28, 2008
POWERLOC CLEAR SAFETY INFUSION SET
K082306
C.R. Bard, Inc.
General Hospital · 15d