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
481–504 of 1176
Cleared Feb 03, 1995
IV BAG PUMP
K940657
I-Flow Corp.
General Hospital · 353d
Cleared Jan 31, 1995
CLAVE NEEDLE-LESS CONNECTOR OPEN EXTENSION SET
K941190
Icu Medical, Inc.
General Hospital · 323d
Cleared Jan 20, 1995
BOLUS DISPENSER
K935811
I-Flow Corp.
General Hospital · 414d
Cleared Jan 13, 1995
VERSASAE PLASTIC CANNULA- 11 GAUGE
K945070
Imed Corp.
General Hospital · 91d
Cleared Dec 13, 1994
IV ADMINISTRATION SET FPA
K944208
Medex, Inc.
General Hospital · 106d
Cleared Oct 04, 1994
PHARMACIA DELTEC EXTENSION SET WITH ANTI-SIPHON VALVE
K942046
Pharmacia Deltec, Inc.
General Hospital · 159d
Cleared Aug 30, 1994
BECTON DICKINSON INTERLINK(TM) LEVER/Y LOCK
K940697
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 195d
Cleared Aug 16, 1994
CHECK VALVE SOLUTION SET
K941453
Douglas Medical Products Corp.
General Hospital · 144d
Cleared Aug 10, 1994
IVAC VENTED SYRINGE ADAPTER ADMINISTRATION SETS
K934095
Y
General Hospital · 352d
Cleared Jul 29, 1994
PROVIDER PUMP SET W/INFUSION CARTRIDGE
K934513
Abbott Laboratories
General Hospital · 317d
Cleared Jul 14, 1994
SOF-SET QR INFUSION SETS, MODELS MMT-115 AND MMT-116
K942181
Medtronic Minimed
General Hospital · 71d
Cleared Jun 29, 1994
EXTENSION SET WITH ANTI-SIPHON VALVE
K941445
Pharmacia Deltec, Inc.
General Hospital · 97d
Cleared Jun 22, 1994
IVAC NEEDLELESS INFECTION VALVE ADMINISTRATION SET
K940897
Y
General Hospital · 118d
Cleared Jun 09, 1994
ENERGIZED DRUG CONTAINER SYSTEM
K934119
Abbott Laboratories
General Hospital · 288d
Cleared May 09, 1994
ISOFLUX IXP FLOW REGULATOR
K925731
Ferguson Medical
General Hospital · 542d
Cleared May 09, 1994
ISOFLUX IXZ FLOW REGULATOR
K925732
Ferguson Medical
General Hospital · 542d
Cleared May 09, 1994
ISOFLUX IXL FLOW REGULATOR
K925733
Ferguson Medical
General Hospital · 542d
Cleared May 05, 1994
CONTROL-A-FLO(TM) REGULATOR
K940867
Baxter Healthcare Corp
General Hospital · 71d
Cleared Apr 15, 1994
PRIMARY ADMIN SET W/UNIV SP-MAN BELOW/ABV PUMP CH
K931173
Imed Corp.
General Hospital · 403d
Cleared Apr 15, 1994
MEASURED VOLUME SOLUTION ADMINISTRATION SET
K940054
Puritas Health Care, Inc.
General Hospital · 100d
Cleared Apr 04, 1994
WINGED INFUSION SET A-PORT VASCULAR ACCESS SYSTEM
K940056
Puritas Health Care, Inc.
General Hospital · 89d
Cleared Mar 28, 1994
LIFECARE PLUMSET VENTED SECONDARY I.V. SET
K933326
Abbott Laboratories
General Hospital · 263d
Cleared Mar 28, 1994
INFUSION ADMINISTRATION SET
K940053
Puritas Health Care, Inc.
General Hospital · 82d
Cleared Mar 23, 1994
I.V. SET (20 DROPS/ML)
K940072
Puritas Health Care, Inc.
General Hospital · 76d