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 B.Braun Medical, Inc..

1176
Total
1176
Cleared
117d
Avg days
1976
Since
1176 devices
97–120 of 1176
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 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 29, 2006
INTERLINK SYSTEM-T-CONNECTOR EXTENSION SET, MODEL 2N3326
K060074
Baxter Healthcare Corp
General Hospital · 78d
Cleared Nov 26, 2004
SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE
K042936
Baxter Healthcare Corp
General Hospital · 32d
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 Jan 27, 2003
LIFESHIELD PRIMARY IV SET CONV. PIN. CLAVE
K030002
Abbott Laboratories
General Hospital · 25d
Cleared Oct 19, 2000
SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE
K003225
Baxter Healthcare Corp
General Hospital · 3d
Cleared Aug 10, 2000
LIFESHIELD ADDITIVE PIERCING PIN
K002006
Abbott Laboratories
General Hospital · 38d
Cleared Jul 26, 1999
LUER ACCESS INJECTION SITE
K984060
Baxter Healthcare Corp
General Hospital · 255d
Cleared Feb 19, 1999
BURETROL SOLUTION SETS
K984381
Baxter Healthcare Corp
General Hospital · 73d
Cleared Sep 04, 1998
COLLEAGUE PUMP SYRINGE ADAPTER SET
K982672
Baxter Healthcare Corp
General Hospital · 35d
Cleared Aug 17, 1998
SOLUTION ADMINISTRATION SET
K981792
Baxter Healthcare Corp
General Hospital · 88d
Cleared May 21, 1998
SOLUTION ADMINISTRATION SET WITH CAPPED LUER ACTIVATED VALVE
K974571
Baxter Healthcare Corp
General Hospital · 164d
Cleared Apr 22, 1998
DUAL LUER LOCK CAP
K981318
Baxter Healthcare Corp
General Hospital · 12d
Cleared Jun 06, 1997
CONTINU-FLO SOLUTION SET
K971701
Baxter Healthcare Corp
General Hospital · 29d
Cleared Apr 02, 1997
INTERLINK MICRO-INFUSION MANIFOLD EXTENSION SETS
K970438
Baxter Healthcare Corp
General Hospital · 56d
Cleared Feb 25, 1997
SOLUTION ADMINISTRATION SET WITH 0.22 MICRON HIGH PRESSURE EXTENDED LIFE FILTER
K964850
Baxter Healthcare Corp
General Hospital · 84d
Cleared Oct 18, 1996
INTERLINK ADAPTER FOR CONVENTIONAL Y-SITE
K962893
Baxter Healthcare Corp
General Hospital · 85d
Cleared Jun 26, 1996
HUBER NEEDLE EXTENSION SET WITH STANDARD Y-INJECTION SITE, INTERLINK Y-INJECTION SITE, INTERLINK T-INJECTION SITE
K961495
Baxter Healthcare Corp
General Hospital · 69d
Cleared Jun 21, 1996
CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SET
K961225
Baxter Healthcare Corp
General Hospital · 84d
Cleared May 29, 1996
ENERGIZED CONTAINER SYSTEM (MODIFICATION)
K954283
Abbott Laboratories
General Hospital · 267d
Cleared May 06, 1996
SNAPDOSE DEVICE
K955410
Abbott Laboratories
General Hospital · 161d
Cleared Oct 24, 1995
LIFESHIELD LUER ACTIVATED VALVE MALE ADAPTER PLUG
K953584
Abbott Laboratories
General Hospital · 84d
Cleared Jul 27, 1995
SOLUTION SET WITH 1.2 MICRON AIR ELIMINATING FILTER
K952074
Baxter Healthcare Corp
General Hospital · 86d