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
169–192 of 1176
Cleared Oct 17, 2012
NIPRO SAFE TOUCH HUBER INFUSION SET
K113470
Nipro Medical Corporation
General Hospital · 330d
Cleared Sep 07, 2012
ZYNO MEDICAL ADMINISTRATION SET
K120685
Zyno Medical, LLC
General Hospital · 185d
Cleared Jul 06, 2012
SAFETY SUBCUTANEOUS TISSUE INFUSION SET
K120195
Multi Med
General Hospital · 165d
Cleared Jun 29, 2012
FLOWEASE [SUBCUTANEOUS] INFUSION SET
K121092
Baxter Healthcare Corp
General Hospital · 80d
Cleared Jun 29, 2012
INTERLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATORY CLEARLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATOR
K121634
Baxter Healthcare Corporation
General Hospital · 25d
Cleared Jun 28, 2012
MED-RX PATIENT DELIVERY SET
K120375
Benlan, Inc.
General Hospital · 143d
Cleared Jun 21, 2012
PRIMARY SYMBIQ SET, DITAL MICROBORE TUBING, 0.2 MICRON FILTER, NON-DEHP
K121032
Hospira, Inc.
General Hospital · 77d
Cleared Jun 08, 2012
Q-FLO CLOSED MALE LUER CONNECTOR
K121554
Us Fusion, LLC. Dba Truecare Biomedix-USA
General Hospital · 14d
Cleared May 30, 2012
NERIA MULTI SUBCUTANEOUS INFUSION SET
K120395
Unomedical Devices S.A DE C.V.
General Hospital · 112d
Cleared May 22, 2012
NEUTRAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH NEUTRAL LUER ACTIVATED DEVICE
K120443
Baxter Healthcare Corporation - Renal Division
General Hospital · 98d
Cleared May 04, 2012
HLIC NEEDLE-LESS VALVE
K120548
Health Line International Corporation
General Hospital · 71d
Cleared May 02, 2012
PPS PI PRESSURE INJECTABLE SAFETY HUBER NEEDLE WITHOUT LATERAL INJECTION SITE, PPS PI PRESSURE INJECTABLE SAFETY HUBER
K120261
Perouse Medical
General Hospital · 96d
Cleared Apr 20, 2012
ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPS
K120872
Unomedical A/S Infusion Devices
General Hospital · 29d
Cleared Apr 18, 2012
NEXUS TKO-6, LUER-ACTIVATED DEVICE
K113398
Nexus Medical, LLC
General Hospital · 153d
Cleared Apr 11, 2012
INFUSITE NEEDLELESS ACCES DEVICE (STERILE, BULK NON-STERILE) AND INFUSITE NEEDLELESS ACCESS DEVICE 'Y' ADAPTER (BULK...
K112073
Rx Devices, LLC
General Hospital · 266d
Cleared Mar 30, 2012
ARISURE NEUTRAL VALVE
K120799
Yukon Medical, LLC
General Hospital · 14d
Cleared Jan 12, 2012
LIFESHIELD VISION INFUSION SET WITH PRE-PIERCED RESEAL
K113683
Hospira, Inc.
General Hospital · 28d
Cleared Dec 23, 2011
MED-RX EXTENSION SET WITH T-CONNECTOR
K112799
Benlan, Inc.
General Hospital · 87d
Cleared Nov 26, 2011
CYTOGUARD(TM) CLOSED LUER CONNECTOR
K112636
B.Braun Medical, Inc.
General Hospital · 78d
Cleared Oct 20, 2011
VANISHPOINT BLOOD COLLECTION SET
K112512
Retractable Technologies, Inc.
General Hospital · 51d
Cleared Oct 18, 2011
CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS
K112893
Baxter Healthcare Corporation
General Hospital · 15d
Cleared Sep 29, 2011
TRUECARE BIOMEDIX INTRAVASCULAR ADMINISTRATION SET, TRUECARE BIOMEDIX EXTENSION SET
K111351
Us Infusion Dba Truecare Biomedix
General Hospital · 139d
Cleared Jul 21, 2011
INFUSION SET FOR POWERPICC SOLO 2 CATHETER
K102405
C.R. Bard, Inc.
General Hospital · 331d
Cleared Jun 23, 2011
CENTURION PRESSURE INJECTABLE EXTENSION SET
K103562
Centurion Medical Products Corporation
General Hospital · 199d