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
Cleared
Apr 15, 2014
MAXZERO EXTENSION SET WITH NEEDLESS CONNECTOR
Care Fusion
General Hospital
13d
Cleared
Apr 03, 2014
SUB-Q SUBCUTANEOUS TISSUE INFUSION SET
Emed Technologies Corporation
General Hospital
76d
Cleared
Mar 20, 2014
CAIR DRIVE, NEUTRACLEAR
Cair Lgl
General Hospital
171d
Cleared
Mar 18, 2014
SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD)
Terumo Europe N.V.
General Hospital
88d
Cleared
Feb 05, 2014
SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)
Terumo Europe N.V.
General Hospital
47d
Cleared
Jan 23, 2014
ZYNO MEDICAL ADMINISTRATION SET
Zyno Medical, LLC
General Hospital
135d
Cleared
Jan 08, 2014
MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLE
Medical Components, Inc.
General Hospital
117d
Cleared
Oct 08, 2013
NERIA SOFT 90 INFUSION SET
Unomedical A/S
General Hospital
89d
Cleared
Oct 08, 2013
NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS
Baxter Healthcare Corp
General Hospital
35d
Cleared
Aug 29, 2013
MZ1000
Care Fusion
General Hospital
27d
Cleared
Jul 09, 2013
NEXUS IV TUBING SET WITH LUER-ACCESSBILE ONE-WAY CHECK VALVE - IV PLUS
Nexus Medical, LLC
General Hospital
102d
Cleared
Jun 12, 2013
NEXUS TKO-6P LUER ACTIVATED DEVICE
Nexus Medical, LLC
General Hospital
113d
Cleared
May 06, 2013
MODEL NUMBER: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614, RMS2-2404, RMS2-2414, RMS3-2604, RMS3-26
Repro-Med Systems, Inc. Dba Rms Medical Products
General Hospital
272d
Cleared
Apr 03, 2013
K100 NEUTRAL DISPLACEMENT NEEDLE FREE CONNECTOR
Np Medical, Inc.
General Hospital
90d
Cleared
Mar 19, 2013
ORBIT INFUSION SET
Ypsomed AG
General Hospital
22d
Cleared
Mar 07, 2013
MACLIN POWER INTRAVASCULAR ADMINISTRATION SET
Maclin Power, Inc.
General Hospital
290d
Cleared
Mar 07, 2013
K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS)
Kawasumi Laboratories, Inc.
General Hospital
127d
Cleared
Jan 22, 2013
TBA
Migada Plant
General Hospital
271d
Cleared
Jan 10, 2013
INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S
Baxter Healthcare Corp
General Hospital
24d
Cleared
Jan 08, 2013
INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET
Baxter Healthcare Corp
General Hospital
22d
Cleared
Dec 21, 2012
VERSARATE FLOW RATE CONTROLER
Emed Technologies Corporation
General Hospital
16d
Cleared
Dec 19, 2012
INTRAVASCULAR ADMINISTRATION SET
Acta Medical, LLC
General Hospital
183d
Cleared
Nov 16, 2012
ACCU-CHEK ULTRAFLEX INFUSION SET
Roche Diabetes Care AG
General Hospital
73d
Cleared
Oct 18, 2012
NIPRO HUBER INFUSION SET, EXCEL HUBER INFUSION SET
Nipro Medical Corporation
General Hospital
331d