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
529–552 of 1176
Cleared Jun 18, 1993
SHROUDED NEEDLE DEVICES
K924718
Imed Corp.
General Hospital · 270d
Cleared Jun 18, 1993
INTERLINK(TM) INJECTION SITE
K925126
Baxter Healthcare Corp
General Hospital · 248d
Cleared May 26, 1993
AVI(TM) MODEL 232 STANDARD IV ADMINISTRATION SET
K924207
3M Health Care, Ltd.
General Hospital · 279d
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 Oct 13, 1992
SUBCUTANEOUS INFUSION SET
K920537
Marquette Medical, Inc.
General Hospital · 251d
Cleared Sep 23, 1992
LIFEPORT INFUSION SET AND INFUSION SET W/ Y SITE
K921674
Strato Medical Corp.
General Hospital · 168d
Cleared Sep 21, 1992
CLAVE CONNECTOR
K915571
Icu Medical, Inc.
General Hospital · 284d
Cleared Sep 02, 1992
SOLUTION ADMINISTRATION SET
K921391
Douglas Medical Products Corp.
General Hospital · 163d
Cleared Jul 30, 1992
MERIT ADMINISTRATION SET
K915678
Merit Medical Systems, Inc.
General Hospital · 224d
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 May 08, 1992
RAPID ADD SITE DOUBLE LUMEN I.V.EXTENSION SET
K915109
Ballard Medical Products
General Hospital · 177d
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 Feb 11, 1992
INJECTION CAP
K913337
Cp Medical
General Hospital · 200d
Cleared Jan 22, 1992
ANGIOGRAPHIC FLUSH SYSTEM
K914113
E-Z-Em, Inc.
General Hospital · 131d
Cleared Jan 10, 1992
MORSE ANESTHESIA
K905208
North American Instrument Corp.
General Hospital · 416d
Cleared Jan 09, 1992
ANGIODYNAMICS ANGIOFILL FLUID MANAGEMENT SYSTEM
K914026
E-Z-Em, Inc.
General Hospital · 121d
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