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
193–216 of 1176
Cleared Jun 09, 2011
SAFEPORT MANIFOLD (TM) (OR STOPCOCK)
K111016
Elcam Medical Acal
General Hospital · 58d
Cleared Apr 27, 2011
LIGHTY DD INFUSION SET
K110282
Medx-Set, Ltd.
General Hospital · 86d
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 Nov 10, 2010
BLOOD SAMPLING SET
K103165
Acacia, Inc.
General Hospital · 14d
Cleared Sep 29, 2010
AMSINO I.V. ADMINISTRATION AND EXTENSION SETS
K101958
Amsino International, Inc.
General Hospital · 79d
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 Aug 03, 2010
GRIPPER MICRO BLUNT CANNULA, NON-CORING SAFETY NEEDLE (GRIPPER MICRO NEEDLE) MODEL: 21-3253-24, 21-3258-24, 21-3262-24,
K101180
Smiths Medical MD, Inc.
General Hospital · 98d
Cleared Aug 02, 2010
INTRAVSCULAR ADMINISTRATION SET
K100946
Terumo Europe N.V.
General Hospital · 118d
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 Apr 26, 2010
NEXUS PRESSURE RATED EXTENSION SETS
K092382
Nexus Medical, LLC
General Hospital · 264d
Cleared Mar 10, 2010
NEXUS INTRAVASCULAR TUBING SETS-PRE-PIERCED
K092930
Nexus Medical, LLC
General Hospital · 169d
Cleared Mar 10, 2010
AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION SET, EXTENSION SETS
K093773
Amsino International, Inc.
General Hospital · 92d
Cleared Feb 04, 2010
NEXUS INJECTION SITE, MODEL NIS-8
K092527
Nexus Medical, LLC
General Hospital · 170d
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