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
217–240 of 1176
Cleared Nov 14, 2008
NEXUS I.V. NEEDLESS ACCESS CANNULA FOR INTRAVASCULAR ADMINISTRATION SETS
K081123
Nexus Medical, LLC
General Hospital · 207d
Cleared Oct 21, 2008
NIPRO SAFETOUCH HUBER INFUSTION SET
K081210
Nipro Medical Corp.
General Hospital · 175d
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
Cleared Jul 18, 2008
CADD MEDICATION CASSETTE RESERVOIR
K081156
Smiths Medical MD, Inc.
General Hospital · 86d
Cleared Dec 13, 2007
SMARTPORT CT MP PORT ACCESS SYSTEM AND LIFEGUARD CT SAFETY INFUSION SET
K072375
AngioDynamics, Inc.
General Hospital · 112d
Cleared Nov 06, 2007
CLEARLINK ANTIMICROBIAL LUER ACTIVATED DEVICE (LAD) AND EXTENSION SETS WITH THE CLEARLINK ANTIMICROBIAL LUER ACTIVATED
K072576
Baxter Healthcare Corp
General Hospital · 54d
Cleared Nov 06, 2007
SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)
K072894
Terumo Europe N.V.
General Hospital · 26d
Cleared Aug 30, 2007
MODIFICATION TO EZ HUBER SAFETY INFUSION SET
K071846
Pfm Medical, Inc.
General Hospital · 56d
Cleared May 25, 2007
SURFLO WINGED INFUSION SET WITH FILTER AND NEEDLE PROTECTION (SURSHIELD)
K070547
Terumo Europe N.V.
General Hospital · 88d
Cleared May 07, 2007
SURFLO WINGED INFUSION SET
K070362
Terumo Europe N.V.
General Hospital · 89d
Cleared Mar 20, 2007
SPIROS
K070532
Icu Medical, Inc.
General Hospital · 22d
Cleared Jul 10, 2006
EZ-CONNECT
K061771
Vidacare Corporation
General Hospital · 17d
Cleared Mar 29, 2006
INTERLINK SYSTEM-T-CONNECTOR EXTENSION SET, MODEL 2N3326
K060074
Baxter Healthcare Corp
General Hospital · 78d
Cleared Jan 10, 2006
TEGO, MODEL D1000
K053106
Icu Medical, Inc.
General Hospital · 67d
Cleared Dec 08, 2005
SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD), MODEL SV-S23BL35VS
K052887
Terumo Europe N.V.
General Hospital · 56d
Cleared Dec 08, 2005
NEXUSTKO NEEDLELESS ACCESS DEVICE, MODEL NIS-5
K053129
Nexus Medical, LLC
General Hospital · 30d
Cleared Nov 29, 2005
MEDTRONIC MINIMED PARADIGM LEAPFROG II INFUSION SET, MODELS MMT-802S1, MMT-802L1, MMT-802S2, MMT-802L2
K052432
Medtronic Minimed
General Hospital · 84d
Cleared Nov 16, 2005
CONTRAST MEDIA TRANSFER SETS
K052252
B.Braun Medical, Inc.
General Hospital · 90d
Cleared Nov 02, 2005
LIFESHIELD LATEX-FREE MICROBORE EXTENSION SET, MODEL 14949 AND OTHERS
K052722
Hospira, Inc.
General Hospital · 34d
Cleared Sep 01, 2005
COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS
K051264
Unomedical A/S
General Hospital · 108d