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
553–576 of 1176
Cleared Aug 02, 1991
3RD HAND HELPER
K911815
Aaron Medical Industries
General Hospital · 100d
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 Jun 04, 1991
4 LOW VOLUME IV EXTENSION SET WITH SLIDE CLAMP
K905218
Marquette Medical, Inc.
General Hospital · 196d
Cleared Jun 04, 1991
4' LOW VOLUME IV EXTENSION SET
K905219
Marquette Medical, Inc.
General Hospital · 196d
Cleared May 31, 1991
IV EXTENSION SETS WITH .22 MICRON FILTER
K905374
Marquette Medical, Inc.
General Hospital · 183d
Cleared Apr 29, 1991
PIGGY LOCK NEEDLE HOUSING
K910546
Icu Medical, Inc.
General Hospital · 82d
Cleared Dec 14, 1990
AVI MODEL 4206 MANIFOLD CHECKVALVE IV ADMIN. SET
K902858
3M Avi, Inc.
General Hospital · 168d
Cleared Nov 21, 1990
EXEL HUBER INFUSION SET WITHOUT INJECTION SITE (Y)
K904685
Exel Intl.
General Hospital · 48d
Cleared Nov 13, 1990
STERILE I.V. START KIT
K902810
Orion Life Systems, Inc.
General Hospital · 139d
Cleared Oct 04, 1990
LOW VOLUME BIFURCATED IV EXTENSION SET
K901088
Marquette Medical, Inc.
General Hospital · 211d
Cleared Oct 04, 1990
LOW VOLUME TRIFURCATED IV EXTENSION SET
K901089
Marquette Medical, Inc.
General Hospital · 211d
Cleared Sep 12, 1990
KAWASUMI Y-TYPE BLOOD ADMINISTRATION SET
K896892
Kawasumi Laboratories Co., Ltd.
General Hospital · 278d
Cleared Sep 12, 1990
KAWASUMI I.V. ADMINISTRATION SET WITH BURETTE
K896893
Kawasumi Laboratories Co., Ltd.
General Hospital · 278d
Cleared Sep 12, 1990
KAWASUMI BLOOD ADMINISTRATION SET
K896894
Kawasumi Laboratories Co., Ltd.
General Hospital · 278d
Cleared Sep 12, 1990
KAWASUMI I.V. ADMINISTRATION SET
K896895
Kawasumi Laboratories Co., Ltd.
General Hospital · 278d
Cleared Sep 12, 1990
KAWASUMI SMALL VEIN INFUSION SET
K896896
Kawasumi Laboratories Co., Ltd.
General Hospital · 278d
Cleared Aug 17, 1990
WINGED INFUSION SET
K902166
Therex Corp.
General Hospital · 94d
Cleared Jul 19, 1990
EXEL HUBER INFUSION SET
K895770
Exel Intl.
General Hospital · 296d
Cleared May 18, 1990
IN-LINE VIAL CONNECTION SITE
K900909
Baxter Healthcare Corp
General Hospital · 80d
Cleared May 01, 1990
ADVANCE CONTRAST MEDIA SETS (VARYING LENGTH)
K900187
Advance Medical Designs, Inc.
Radiology · 105d
Cleared May 01, 1990
ADVANCE ADMINISTRATION SETS (VARYING LENGTH)
K900188
Advance Medical Designs, Inc.
Radiology · 105d
Cleared Feb 28, 1990
IV BIFURCATED EXTENSION SET
K900426
Marquette Medical, Inc.
General Hospital · 29d
Cleared Feb 28, 1990
IV TRIFURCATED EXTENSION SET
K900427
Marquette Medical, Inc.
General Hospital · 29d