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 May 28, 2015
Imed Technology Intravascular Administration Set, Imed Technology Extension Set
K150513
Imed Technology, Inc.
General Hospital · 90d
Cleared Apr 28, 2015
BD FlowSmart Set
K150059
Becton, Dickinson Company
General Hospital · 105d
Cleared Apr 16, 2015
Nitroglycerin Sets with DUO-VENT Spike
K150860
Baxter Healthcare Corporation
General Hospital · 15d
Cleared Mar 04, 2015
Hospira Blood Set
K143087
Hospira, Inc.
General Hospital · 128d
Cleared Feb 25, 2015
Hospira Primary Sets
K143015
Hospira, Inc.
General Hospital · 128d
Cleared Feb 19, 2015
BUSSE EXTENSION SET
K141285
Busse Hospital Disposables
General Hospital · 279d
Cleared Jan 16, 2015
All Safe Huber Safety Infusion Set
K142590
Nexus Medical, LLC
General Hospital · 123d
Cleared Jan 15, 2015
IV Administration
K142622
Hospira, Inc.
General Hospital · 121d
Cleared Jan 09, 2015
Extension Sets
K142974
Hospira, Inc.
General Hospital · 87d
Cleared Dec 08, 2014
Hospira Extension Set
K142433
Hospira, Inc.
General Hospital · 101d
Cleared Dec 05, 2014
IV ADMINISTRATION SET WITH HAND PUMP
K140838
B.Braun Medical, Inc.
General Hospital · 247d
Cleared Nov 25, 2014
Hospira Primary Sets
K142367
Hospira, Inc.
General Hospital · 92d
Cleared Nov 20, 2014
MaxZero Administration Sets
K143234
Care Fusion
General Hospital · 10d
Cleared Oct 02, 2014
PADI-LOCK
K141200
Padi-Lock, LLC
General Hospital · 146d
Cleared Sep 19, 2014
Extension Set with BD Q-Syte Luer Access Split Septum
K142527
Acacia, Inc.
General Hospital · 11d
Cleared Aug 29, 2014
SELEC-3 I.V.ADMINISTRATION SET
K142097
Biomedix, Inc.
General Hospital · 28d
Cleared Aug 25, 2014
INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETS
K142036
B.Braun Medical, Inc.
General Hospital · 28d
Cleared Aug 18, 2014
SOLUTION SET/EXTENSION SET
K142011
Baxter Healthcare Corporation
General Hospital · 25d
Cleared Aug 05, 2014
INTRAVASCULAR ADMINISTRATION SET
K140175
Delta Med Spa
General Hospital · 194d
Cleared Aug 05, 2014
SAPPHIRE ADMINISTRATION SET
K141834
Q Core Medical , Ltd.
General Hospital · 29d
Cleared Jun 12, 2014
TEVADAPTOR
K141306
Teva Medical Ltd., Migada Plant
General Hospital · 24d
Cleared May 22, 2014
NEXUS NIS-6P LUER ACTIVATED DEVICE
K133351
Nexus Medical, LLC
General Hospital · 203d
Cleared May 15, 2014
INFUSET FLOW CONTROL EXTENSION SET
K140133
Emed Technologies Corporation
General Hospital · 118d
Cleared May 07, 2014
CARESITE LUER ACCESS DEVICE
K140311
B.Braun Medical, Inc.
General Hospital · 89d