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
Aug 25, 1999
MED-RX EXTENSION SETS
Benlan, Inc.
General Hospital
169d
Cleared
Aug 23, 1999
PARSET, MODEL A10001E
Rd Medical Mfg., Inc.
General Hospital
62d
Cleared
Aug 20, 1999
INTRAVASCULAR ADMINISTRATION SET
The Kipp Group
General Hospital
73d
Cleared
Aug 20, 1999
COOK HIGH VOLUME INFUSION ADAPTER INTRAVASCULAR ADMINISTRATION SET
Cook, Inc.
General Hospital
67d
Cleared
Aug 12, 1999
AB2 MED-FLO SOLUTION SET
Ab2 Medical Products, Llp
General Hospital
232d
Cleared
Jul 26, 1999
LUER ACCESS INJECTION SITE
Baxter Healthcare Corp
General Hospital
255d
Cleared
Jul 01, 1999
ANESFLOW-DUAL DRIP IV INFUSION SET
Innovative Design Assoc.
General Hospital
134d
Cleared
Jun 25, 1999
MAERSK MEDICAL CONTOUR INFUSION SET
Maersk Medical A/S
General Hospital
32d
Cleared
Jun 24, 1999
INVISION-PLUS INJECTION PORT CONNECTOR SYSTEM
Rymed Technologies, Inc.
General Hospital
42d
Cleared
Jun 21, 1999
HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVO
I-Flow Corp.
General Hospital
52d
Cleared
Jun 15, 1999
CADD ADMINISTRATION SET
Sims Deltec, Inc.
General Hospital
36d
Cleared
Jun 09, 1999
CADD-TPN ADMINISTRATION SET, MODEL 21-7071
Sims Deltec, Inc.
General Hospital
57d
Cleared
Jun 09, 1999
CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPHON VALVE, CADD ADMINISTRATION SET WITH 1
Sims Deltec, Inc.
General Hospital
54d
Cleared
May 14, 1999
FLEXNEEDLE PLUS
Act Medical, Inc.
General Hospital
72d
Cleared
Mar 29, 1999
TUTOPLUS IV ADMINISTRATION SET
Myco Medical Supplies, Inc.
General Hospital
49d
Cleared
Mar 01, 1999
TUTODROP 1 AND TUTODROP 2
Myco Medical Supplies, Inc.
General Hospital
259d
Cleared
Feb 24, 1999
FREE FLOW SAFETY DEVICE, MODEL MG 245052
Teva Medical, Ltd.
General Hospital
26d
Cleared
Feb 22, 1999
KVO CHECK VALVE ACCESSORY, MODEL EV-0001
I-Flow Corp.
General Hospital
70d
Cleared
Feb 19, 1999
BURETROL SOLUTION SETS
Baxter Healthcare Corp
General Hospital
73d
Cleared
Feb 12, 1999
CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER
Sims Deltec, Inc.
General Hospital
32d
Cleared
Feb 09, 1999
COLORVEES IV SET 20 DROPS/ML 105, 60 DROPS/ML 105, VENTED 20 DROPS 105, VENTED 60 DROPS 105
Valnet Medical Corp.
General Hospital
134d
Cleared
Feb 09, 1999
PARAGON BASAL/BOLUS ADMINISTRATION SET
I-Flow Corp.
General Hospital
85d
Cleared
Feb 09, 1999
PARAGON INFUSION
I-Flow Corp.
General Hospital
82d
Cleared
Feb 09, 1999
PARAGON BOLUS ACCESSORY SET
I-Flow Corp.
General Hospital
40d