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
721–744 of 1176
Cleared Jun 11, 1981
MODELS: 52-01-0, 52-01-1
K811110
Y
General Hospital · 49d
Cleared May 29, 1981
VENTED PRIMARY PIGGYBACK VENOSET DUAL
K810239
Abbott Laboratories
General Hospital · 121d
Cleared May 27, 1981
NITROGLYCERINE IV SET
K810317
Abbott Laboratories
General Hospital · 110d
Cleared Mar 31, 1981
HAEMONETICS 170 Y INFUSION SET
K810365
Haemonetics Corp.
General Hospital · 47d
Cleared Oct 03, 1980
DISPOSABLE CONSTRAST DELIVERY SPIKE KIT
K802329
Stanco Medical, Inc.
General Hospital · 10d
Cleared Aug 27, 1980
PRIMARY SOLUTION ADMIN. SET-#86-01-0 260
K801871
Y
General Hospital · 22d
Cleared Aug 27, 1980
MODEL 86-01-1 260 SOLUTION ADMIN. SET
K801872
Y
General Hospital · 22d
Cleared Aug 27, 1980
MODEL 86-21-0 260 SECONDARY MEDICATION
K801873
Y
General Hospital · 22d
Cleared Aug 27, 1980
MODEL 86-21-1 260 APPROX. 60 DROPS/VENTD
K801874
Y
General Hospital · 22d
Cleared Aug 12, 1980
MCGRAW I.V. ADMINISTRATION SET
K801540
American Hospital Supply Corp.
General Hospital · 40d
Cleared Aug 12, 1980
MODEL 72-81-0 UNVENTED SOLUTION ADM. SET
K801613
Y
General Hospital · 28d
Cleared May 08, 1980
VOLUMETRIC PUMP CASSETTE W/ATTACHED SET
K800711
Travenol Laboratories, S.A.
General Hospital · 38d
Cleared Apr 16, 1980
Y-TYPE INFUSION SET (2 LEAD)
K800358
Haemonetics Corp.
General Hospital · 56d
Cleared Apr 16, 1980
MCGAW/EPIC I.V. ADMIN. SET
K800403
American Hospital Supply Corp.
General Hospital · 50d
Cleared Apr 16, 1980
B-D STASET, I.V. FLOW CONTROLLER
K800600
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 30d
Cleared Apr 08, 1980
LOW PLASTICIZER ADMINISTRATION SETS
K791496
Travenol Laboratories, S.A.
General Hospital · 249d
Cleared Mar 20, 1980
PRI. PIGGYBACK I.V. W/DUAL PIERCING PIN
K800137
Abbott Laboratories
General Hospital · 59d
Cleared Jan 16, 1980
VENTED I.V. SET
K792228
Abbott Laboratories
General Hospital · 72d
Cleared Dec 20, 1979
CONTINU-FLO ADMIN. SET CODE 2C/200
K792538
Travenol Laboratories, S.A.
General Hospital · 10d
Cleared Oct 26, 1979
ALBUMIN INTRAVENOUS ADMINISTRATION SET
K791672
Delmed, Inc.
General Hospital · 59d
Cleared Oct 26, 1979
IV EXTENSION SET SL
K791930
Abbott Laboratories
General Hospital · 29d
Cleared Jul 30, 1979
SURFLO INJECTION PLUG
K791173
Terumo America, Inc.
General Hospital · 35d
Cleared May 29, 1979
INTRAVASCULAR ADMINISTRATION SET
K790582
Y
General Hospital · 63d
Cleared May 04, 1979
CUSTOM TUBING SETS
K790604
Norton Performance Plastics Corp.
General Hospital · 46d