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
145–168 of 1176
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 Mar 20, 2007
SPIROS
K070532
Icu Medical, Inc.
General Hospital · 22d
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 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 Aug 03, 2005
CML 1000
K051437
Icu Medical, Inc.
General Hospital · 63d
Cleared Jul 13, 2005
ANGIODYNAMICS TUMESCENT INFUSION DEVICE
K051142
AngioDynamics, Inc.
General Hospital · 70d
Cleared Apr 07, 2005
BD POSIFLOW POSITIVE DISPLACEMENT VALVE
K050207
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital · 69d
Cleared Nov 26, 2004
SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE
K042936
Baxter Healthcare Corp
General Hospital · 32d
Cleared Oct 29, 2004
IV ADMINISTRATION SETS WITH ULTRABLOCK UV-RESISTANT TUBING
K041490
B.Braun Medical, Inc.
General Hospital · 147d
Cleared Sep 01, 2004
Y CLAVE CONNECTOR WITH INTEGRATED CHECK VALVE, MODEL XI-3432
K042182
Icu Medical, Inc.
General Hospital · 21d
Cleared Aug 11, 2004
TEGO NEEDLE FREE ACCESS ACCESS DEVICE
K040710
Icu Medical, Inc.
General Hospital · 146d
Cleared Jul 28, 2004
PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION, MODEL 5118
K041410
Icu Medical, Inc.
General Hospital · 62d
Cleared Jul 16, 2004
SPLIT SEPTUM INJECTION SITES
K041042
Fresenius Medical Care North America
General Hospital · 85d
Cleared Apr 12, 2004
TALON INFUSION SET, MODEL IP XXXX
K033290
Icu Medical, Inc.
General Hospital · 181d
Cleared Apr 07, 2004
MULTIPORT MANIFOLD SET WITH SWABABLE VALVES, MODEL 9900
K040385
Quest Medical, Inc.
General Hospital · 50d
Cleared Dec 04, 2003
CLC2000 CATHETER PATENCY DEVICE
K021692
Icu Medical, Inc.
General Hospital · 561d
Cleared Dec 04, 2003
LIFESHIELD LATEX-FREE PRIMARY IV PUMP SET DISTAL MICROBORE PATIENT LINE, CONVERTIBLE PIN, 72 INCH, WITH 2 PRESSURE
K033576
Abbott Laboratories
General Hospital · 21d
Cleared Nov 18, 2003
BD VACUTAINER SAFETY-LOK ADMINISTRATION SET WITH FILTER
K033350
Becton, Dickinson & CO
General Hospital · 29d
Cleared Oct 28, 2003
MEDTRONIC MINIMED PARADIGM COUNTACH INFUSION SET, MODEL MMT 310
K032484
Medtronic Minimed
General Hospital · 77d
Cleared Oct 28, 2003
MEDTRONIC MINIMED COUNTACH INFUSION SET, MODEL 313
K032485
Medtronic Minimed
General Hospital · 77d