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
121–144 of 1176
Cleared Jun 21, 2012
PRIMARY SYMBIQ SET, DITAL MICROBORE TUBING, 0.2 MICRON FILTER, NON-DEHP
K121032
Hospira, Inc.
General Hospital · 77d
Cleared Jan 12, 2012
LIFESHIELD VISION INFUSION SET WITH PRE-PIERCED RESEAL
K113683
Hospira, Inc.
General Hospital · 28d
Cleared Nov 26, 2011
CYTOGUARD(TM) CLOSED LUER CONNECTOR
K112636
B.Braun Medical, Inc.
General Hospital · 78d
Cleared Oct 18, 2011
CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS
K112893
Baxter Healthcare Corporation
General Hospital · 15d
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 Jan 07, 2011
HOSPIRA PLUM INFUSION SET
K103224
Hospira, Inc.
General Hospital · 67d
Cleared Dec 17, 2010
HIGH PRESSURE SETS-400 PSI
K100576
Icu Medical, Inc.
General Hospital · 291d
Cleared Dec 10, 2010
INFUSION SETS
K103344
Hospira, Inc.
General Hospital · 25d
Cleared Aug 27, 2010
ACCU-CHEK ULTRFLEX INFUSION SET
K101196
Roche Diagnostics Corp.
General Hospital · 120d
Cleared Aug 11, 2010
HOSPIRA INFUSION BLOOD SETS
K101677
Hospira, Inc.
General Hospital · 57d
Cleared Jul 09, 2010
POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS
K100432
Medtronic Minimed
General Hospital · 143d
Cleared Jul 09, 2010
CLAVE NEUTRON
K100434
Icu Medical, Inc.
General Hospital · 143d
Cleared Jun 22, 2010
DUAL LUER LOCK CAP, MODEL 2C6250
K101385
Baxter Healthcare Corp
General Hospital · 35d
Cleared Jun 05, 2009
A6 LUER ACCESS DEVICE
K083723
B.Braun Medical, Inc.
General Hospital · 172d
Cleared Apr 21, 2009
INTRAVENOUS POWER INJECTOR EXTENSION SET
K090134
C.R. Bard, Inc.
General Hospital · 90d
Cleared Apr 10, 2009
ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVE
K090189
Icu Medical, Inc.
General Hospital · 74d
Cleared Apr 06, 2009
SPINNING SPIROS, MODEL CH-2000
K082806
Icu Medical, Inc.
General Hospital · 194d
Cleared Dec 23, 2008
MISER CONTRAST MANAGEMENT SYSTEM
K083576
Merit Medical Systems, Inc.
General Hospital · 20d
Cleared Aug 28, 2008
CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM, MODEL, CH-XXXX
K081361
Icu Medical, Inc.
General Hospital · 105d
Cleared Aug 28, 2008
POWERLOC CLEAR SAFETY INFUSION SET
K082306
C.R. Bard, Inc.
General Hospital · 15d
Cleared Aug 14, 2008
UNASSIGNED
K080544
Medcomp
General Hospital · 169d
Cleared Aug 07, 2008
ANTIMICROBIAL ULTRASITE VALUE, ULTRASITE AG
K073396
B.Braun Medical, Inc.
General Hospital · 248d
Cleared Aug 04, 2008
V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE
K081289
Baxter Healthcare Corp
General Hospital · 89d