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
Jun 15, 1987
IV PUMP SET
Churchill Corp.
General Hospital
89d
Cleared
Jun 15, 1987
CHURCHILL-H VENTED IV SET W/METERING CHAMBERS
Churchill Corp.
General Hospital
41d
Cleared
Apr 23, 1987
LIFEPORT(R) 7 INCH CONTINUOUS INFUSION SET
Strato Medical Corp.
General Hospital
71d
Cleared
Apr 23, 1987
LIFEPORT(R) 7 INCH CONTINUOUS INFUSION W/Y-SITE
Strato Medical Corp.
General Hospital
71d
Cleared
Mar 17, 1987
SOLUTION ADMINI. SETS- ALTER. DRIP CHAMBER/CONNEC.
Travenol Laboratories, S.A.
General Hospital
8d
Cleared
Feb 10, 1987
NORFOLK MEDICAL BUTTERFLY INFUSION SET
Norfolk Medical Products, Inc.
General Hospital
25d
Cleared
Dec 18, 1986
MANAN CONTRAST MEDIA ADMINISTRATION SET
Manan Manufacturing Co., Inc.
General Hospital
38d
Cleared
Dec 16, 1986
CRIS ADAPTED WITH VOLUME LIMITING BAG
Y
General Hospital
54d
Cleared
Nov 19, 1986
SECONDARY SET LOCK
Travenol Laboratories, S.A.
General Hospital
15d
Cleared
Oct 14, 1986
BAG SPIKE EXTENSION SET
Med Fusion Systems, Inc.
General Hospital
14d
Cleared
Aug 27, 1986
EXEL BUTTERFLY SCALP VEIN SET
Exel Intl.
General Hospital
57d
Cleared
Jul 31, 1986
LUER LOCK ADAPTER/NUT
Mallinckrodt Critical Care
General Hospital
17d
Cleared
Jun 04, 1986
TIMELINE VENIPUNCTURE SYSTEM
Ipax, Inc.
General Hospital
105d
Cleared
Jun 04, 1986
TIMELINE VENIPUNCTURE SYSTEM
Ipax, Inc.
General Hospital
65d
Cleared
Jun 02, 1986
VOLUME CONTROL SET WITH EXTENSION
Med Fusion Systems, Inc.
General Hospital
103d
Cleared
May 12, 1986
CHURCHILL INJECTION SITE
Churchill Corp.
General Hospital
26d
Cleared
May 06, 1986
CHURCHILL FEMALE LUER LOCK CAP
Churchill Corp.
General Hospital
19d
Cleared
Apr 09, 1986
NITROGLYCERIN INTRAVASCULAR ADMINISTRATION SET
Quest Medical, Inc.
General Hospital
83d
Cleared
Apr 07, 1986
CLINISET INFUSION SET
Zimmar Consulting , Ltd.
General Hospital
68d
Cleared
Mar 25, 1986
SOLUTION ADMINISTRATION SET
Travenol Laboratories, S.A.
General Hospital
41d
Cleared
Mar 18, 1986
SOLUTION ADMINISTRATION SETS
Travenol Laboratories, S.A.
General Hospital
50d
Cleared
Jan 27, 1986
CHURCHILL - HBC VENTED BALL CHECK IV SET
Churchill Corp.
General Hospital
68d
Cleared
Jan 23, 1986
IVAC CONTROLLED RELEASE INFUSION SYSTEM
Y
General Hospital
79d
Cleared
Jan 09, 1986
TERUMO TERUFUSION BLOOD & Y-TYPE ADMIN. SET
Terumo Medical Corp.
General Hospital
65d