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
625–648 of 1176
Cleared Jun 15, 1987
IV PUMP SET
K871086
Churchill Corp.
General Hospital · 89d
Cleared Jun 15, 1987
CHURCHILL-H VENTED IV SET W/METERING CHAMBERS
K871732
Churchill Corp.
General Hospital · 41d
Cleared Apr 23, 1987
LIFEPORT(R) 7 INCH CONTINUOUS INFUSION SET
K870581
Strato Medical Corp.
General Hospital · 71d
Cleared Apr 23, 1987
LIFEPORT(R) 7 INCH CONTINUOUS INFUSION W/Y-SITE
K870582
Strato Medical Corp.
General Hospital · 71d
Cleared Mar 17, 1987
SOLUTION ADMINI. SETS- ALTER. DRIP CHAMBER/CONNEC.
K870940
Travenol Laboratories, S.A.
General Hospital · 8d
Cleared Feb 10, 1987
NORFOLK MEDICAL BUTTERFLY INFUSION SET
K870188
Norfolk Medical Products, Inc.
General Hospital · 25d
Cleared Dec 18, 1986
MANAN CONTRAST MEDIA ADMINISTRATION SET
K864405
Manan Manufacturing Co., Inc.
General Hospital · 38d
Cleared Dec 16, 1986
CRIS ADAPTED WITH VOLUME LIMITING BAG
K864164
Y
General Hospital · 54d
Cleared Nov 19, 1986
SECONDARY SET LOCK
K864338
Travenol Laboratories, S.A.
General Hospital · 15d
Cleared Oct 14, 1986
BAG SPIKE EXTENSION SET
K863814
Med Fusion Systems, Inc.
General Hospital · 14d
Cleared Aug 27, 1986
EXEL BUTTERFLY SCALP VEIN SET
K862491
Exel Intl.
General Hospital · 57d
Cleared Jul 31, 1986
LUER LOCK ADAPTER/NUT
K862653
Mallinckrodt Critical Care
General Hospital · 17d
Cleared Jun 04, 1986
TIMELINE VENIPUNCTURE SYSTEM
K860609
Ipax, Inc.
General Hospital · 105d
Cleared Jun 04, 1986
TIMELINE VENIPUNCTURE SYSTEM
K861182
Ipax, Inc.
General Hospital · 65d
Cleared Jun 02, 1986
VOLUME CONTROL SET WITH EXTENSION
K860616
Med Fusion Systems, Inc.
General Hospital · 103d
Cleared May 12, 1986
CHURCHILL INJECTION SITE
K861430
Churchill Corp.
General Hospital · 26d
Cleared May 06, 1986
CHURCHILL FEMALE LUER LOCK CAP
K861439
Churchill Corp.
General Hospital · 19d
Cleared Apr 09, 1986
NITROGLYCERIN INTRAVASCULAR ADMINISTRATION SET
K860157
Quest Medical, Inc.
General Hospital · 83d
Cleared Apr 07, 1986
CLINISET INFUSION SET
K860322
Zimmar Consulting , Ltd.
General Hospital · 68d
Cleared Mar 25, 1986
SOLUTION ADMINISTRATION SET
K860541
Travenol Laboratories, S.A.
General Hospital · 41d
Cleared Mar 18, 1986
SOLUTION ADMINISTRATION SETS
K860272
Travenol Laboratories, S.A.
General Hospital · 50d
Cleared Jan 27, 1986
CHURCHILL - HBC VENTED BALL CHECK IV SET
K854658
Churchill Corp.
General Hospital · 68d
Cleared Jan 23, 1986
IVAC CONTROLLED RELEASE INFUSION SYSTEM
K854574
Y
General Hospital · 79d
Cleared Jan 09, 1986
TERUMO TERUFUSION BLOOD & Y-TYPE ADMIN. SET
K854446
Terumo Medical Corp.
General Hospital · 65d