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 B.Braun Medical, Inc..

1176
Total
1176
Cleared
117d
Avg days
1976
Since
1176 devices
121–144 of 1176
Cleared Aug 30, 1994
BECTON DICKINSON INTERLINK(TM) LEVER/Y LOCK
K940697
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 195d
Cleared Jul 29, 1994
PROVIDER PUMP SET W/INFUSION CARTRIDGE
K934513
Abbott Laboratories
General Hospital · 317d
Cleared Jun 09, 1994
ENERGIZED DRUG CONTAINER SYSTEM
K934119
Abbott Laboratories
General Hospital · 288d
Cleared May 05, 1994
CONTROL-A-FLO(TM) REGULATOR
K940867
Baxter Healthcare Corp
General Hospital · 71d
Cleared Mar 28, 1994
LIFECARE PLUMSET VENTED SECONDARY I.V. SET
K933326
Abbott Laboratories
General Hospital · 263d
Cleared Nov 03, 1993
ENERGIZED CONTAINER SYSTEM
K925418
Abbott Laboratories
General Hospital · 372d
Cleared Aug 28, 1993
SUB-Q-SET(R) SUBCUTANEOUS INFUSION SET
K925362
Baxter Healthcare Corp
General Hospital · 310d
Cleared Aug 03, 1993
BARD AMBU PUMP SPIK TUB SET PACRET PROVID PUMP SET
K925058
C.R. Bard, Inc.
General Hospital · 301d
Cleared Jul 20, 1993
BAXTER SOLUTION ADMINISTRATION SETS
K924721
Baxter Healthcare Corp
General Hospital · 302d
Cleared Jun 18, 1993
INTERLINK(TM) INJECTION SITE
K925126
Baxter Healthcare Corp
General Hospital · 248d
Cleared Apr 20, 1993
INTERLINK SYSTEM - T-CONNECTOR EXTENSION SET
K921899
Baxter Healthcare Corp
General Hospital · 363d
Cleared Nov 05, 1992
LIFESHIELD ANESTHESIA SET
K913982
Abbott Laboratories
General Hospital · 427d
Cleared Oct 19, 1992
INTERLINK(TM) INJECTION SITE
K922558
Baxter Healthcare Corp
General Hospital · 144d
Cleared Jun 04, 1992
CONTINU-FLO(R) SOLUTION SET
K921703
Baxter Healthcare Corp
General Hospital · 55d
Cleared May 15, 1992
INJECTION SITE WITH LUER LOCK
K915828
Baxter Healthcare Corp
General Hospital · 137d
Cleared Mar 23, 1992
8000 SERIES VOLUMETRIC PUMP NON-GRAVITY FLOW SET
K920694
Baxter Healthcare Corp
General Hospital · 38d
Cleared Mar 12, 1992
3 LEAD EXTENSION WITH 2 INTERLINK INJECTION SITES
K915390
Baxter Healthcare Corp
General Hospital · 104d
Cleared Nov 27, 1991
NEEDLE*LOCK(TM) WITH INTERLINK(TM) INJECTION SITE
K914048
Baxter Healthcare Corp
General Hospital · 78d
Cleared Oct 21, 1991
8000 SERIES VOLUMETRIC PUMP SOLUTION SET
K914074
Baxter Healthcare Corp
General Hospital · 40d
Cleared Sep 23, 1991
3 PORT ADAPTER
K913627
Baxter Healthcare Corp
General Hospital · 39d
Cleared Sep 11, 1991
VOLUMETRIC PUMP SOLUTION SET MODIFIED CASSETTE
K912141
Baxter Healthcare Corp
General Hospital · 120d
Cleared Jun 24, 1991
INTERLINK(TM) BLUNT CANNULA, MODIFICATION
K911868
Baxter Healthcare Corp
General Hospital · 59d
Cleared Jun 14, 1991
B-D SAFETY-LOK(TM) I.V. NEEDLES
K911136
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 92d
Cleared May 18, 1990
IN-LINE VIAL CONNECTION SITE
K900909
Baxter Healthcare Corp
General Hospital · 80d