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
241–264 of 1176
Cleared Aug 23, 2005
VITALCARE I.V. ADMINISTRATION SET
K050906
Vitalcare Group, Inc.
General Hospital · 134d
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 Jul 12, 2005
HUBER CLEAR SAFETY INFUSION SET
K051009
Now Medical Distribution, Inc.
General Hospital · 82d
Cleared Jun 22, 2005
INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET
K051499
Medegen Medical Manufacturing Services
General Hospital · 15d
Cleared May 12, 2005
MINILOC SAFETY INFUSION SET
K050600
Specialized Health Products, Intl.
General Hospital · 64d
Cleared Apr 15, 2005
PENTADEFLUE IV SOLUTION ADMINISTRATION SETS
K041495
Pentaferte S.P.A
General Hospital · 315d
Cleared Apr 15, 2005
MICROFLO-SAFE SCALP VEIN SET
K043328
Dks Loversan Industria Biomedica Spa
General Hospital · 134d
Cleared Apr 07, 2005
BD POSIFLOW POSITIVE DISPLACEMENT VALVE
K050207
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital · 69d
Cleared Mar 08, 2005
DRAGON HEART I.V. SET
K043235
Dragon Heart Medical Devices Co., Ltd.
General Hospital · 106d
Cleared Jan 27, 2005
F00010 - IV GRAVITY SETWITH MALE LUER SLIP
K042129
Cedic S.R.L.
General Hospital · 174d
Cleared Dec 21, 2004
LUTH-ALL SUB-Q NEEDLE SET
K042666
Luth-All Medical Products, LLC
General Hospital · 83d
Cleared Nov 26, 2004
NEXUS INTRAVENOUS TUBING SETS (NIVTS)
K041861
Nexus Medical, LLC
General Hospital · 140d
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 Oct 21, 2004
IV ADMINISTRATION SET B400 SP
K042693
Codan US Corp.
General Hospital · 21d
Cleared Oct 07, 2004
CLEO 90 INFUSION SET
K042172
Smiths Medical MD, Inc.
General Hospital · 57d
Cleared Oct 04, 2004
PERFUDROP AIR M-P WITH NEEDLE 20 G, MODEL 48451606
K041919
Clinico
General Hospital · 80d
Cleared Sep 17, 2004
EZ HUBER SAFETY INFUSION SET
K040533
Pfm Medical, Inc.
General Hospital · 200d
Cleared Sep 08, 2004
MODIFICATION TO: LIFTLOC SAFTEY INFUSION SET
K042234
Specialty Health Products, Inc.
General Hospital · 21d
Cleared Sep 03, 2004
ALL SAFE HUBER SAFETY INFUSION SETS
K041844
Nexus Medical, LLC
General Hospital · 57d
Cleared Sep 01, 2004
Y CLAVE CONNECTOR WITH INTEGRATED CHECK VALVE, MODEL XI-3432
K042182
Icu Medical, Inc.
General Hospital · 21d
Cleared Aug 24, 2004
NEXUS PAV LUER LOCK DEVICE, MODEL NIS-4
K041845
Nexus Medical, LLC
General Hospital · 47d
Cleared Aug 11, 2004
TEGO NEEDLE FREE ACCESS ACCESS DEVICE
K040710
Icu Medical, Inc.
General Hospital · 146d