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
145–168 of 1176
Cleared Apr 15, 2014
MAXZERO EXTENSION SET WITH NEEDLESS CONNECTOR
K140831
Care Fusion
General Hospital · 13d
Cleared Apr 03, 2014
SUB-Q SUBCUTANEOUS TISSUE INFUSION SET
K140131
Emed Technologies Corporation
General Hospital · 76d
Cleared Mar 20, 2014
CAIR DRIVE, NEUTRACLEAR
K133073
Cair Lgl
General Hospital · 171d
Cleared Mar 18, 2014
SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD)
K133894
Terumo Europe N.V.
General Hospital · 88d
Cleared Feb 05, 2014
SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)
K133867
Terumo Europe N.V.
General Hospital · 47d
Cleared Jan 23, 2014
ZYNO MEDICAL ADMINISTRATION SET
K132841
Zyno Medical, LLC
General Hospital · 135d
Cleared Jan 08, 2014
MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLE
K132880
Medical Components, Inc.
General Hospital · 117d
Cleared Oct 08, 2013
NERIA SOFT 90 INFUSION SET
K132142
Unomedical A/S
General Hospital · 89d
Cleared Oct 08, 2013
NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS
K132734
Baxter Healthcare Corp
General Hospital · 35d
Cleared Aug 29, 2013
MZ1000
K132413
Care Fusion
General Hospital · 27d
Cleared Jul 09, 2013
NEXUS IV TUBING SET WITH LUER-ACCESSBILE ONE-WAY CHECK VALVE - IV PLUS
K130879
Nexus Medical, LLC
General Hospital · 102d
Cleared Jun 12, 2013
NEXUS TKO-6P LUER ACTIVATED DEVICE
K130416
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
K122404
Repro-Med Systems, Inc. Dba Rms Medical Products
General Hospital · 272d
Cleared Apr 03, 2013
K100 NEUTRAL DISPLACEMENT NEEDLE FREE CONNECTOR
K130023
Np Medical, Inc.
General Hospital · 90d
Cleared Mar 19, 2013
ORBIT INFUSION SET
K130468
Ypsomed AG
General Hospital · 22d
Cleared Mar 07, 2013
MACLIN POWER INTRAVASCULAR ADMINISTRATION SET
K121511
Maclin Power, Inc.
General Hospital · 290d
Cleared Mar 07, 2013
K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS)
K123344
Kawasumi Laboratories, Inc.
General Hospital · 127d
Cleared Jan 22, 2013
TBA
K121269
Migada Plant
General Hospital · 271d
Cleared Jan 10, 2013
INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S
K123874
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
K123868
Baxter Healthcare Corp
General Hospital · 22d
Cleared Dec 21, 2012
VERSARATE FLOW RATE CONTROLER
K123729
Emed Technologies Corporation
General Hospital · 16d
Cleared Dec 19, 2012
INTRAVASCULAR ADMINISTRATION SET
K121803
Acta Medical, LLC
General Hospital · 183d
Cleared Nov 16, 2012
ACCU-CHEK ULTRAFLEX INFUSION SET
K122686
Roche Diabetes Care AG
General Hospital · 73d
Cleared Oct 18, 2012
NIPRO HUBER INFUSION SET, EXCEL HUBER INFUSION SET
K113471
Nipro Medical Corporation
General Hospital · 331d