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
337–360 of 1176
Cleared Aug 25, 1999
MED-RX EXTENSION SETS
K990777
Benlan, Inc.
General Hospital · 169d
Cleared Aug 23, 1999
PARSET, MODEL A10001E
K992104
Rd Medical Mfg., Inc.
General Hospital · 62d
Cleared Aug 20, 1999
INTRAVASCULAR ADMINISTRATION SET
K991932
The Kipp Group
General Hospital · 73d
Cleared Aug 20, 1999
COOK HIGH VOLUME INFUSION ADAPTER INTRAVASCULAR ADMINISTRATION SET
K991985
Cook, Inc.
General Hospital · 67d
Cleared Aug 12, 1999
AB2 MED-FLO SOLUTION SET
K984569
Ab2 Medical Products, Llp
General Hospital · 232d
Cleared Jul 26, 1999
LUER ACCESS INJECTION SITE
K984060
Baxter Healthcare Corp
General Hospital · 255d
Cleared Jul 01, 1999
ANESFLOW-DUAL DRIP IV INFUSION SET
K990496
Innovative Design Assoc.
General Hospital · 134d
Cleared Jun 25, 1999
MAERSK MEDICAL CONTOUR INFUSION SET
K991759
Maersk Medical A/S
General Hospital · 32d
Cleared Jun 24, 1999
INVISION-PLUS INJECTION PORT CONNECTOR SYSTEM
K991653
Rymed Technologies, Inc.
General Hospital · 42d
Cleared Jun 21, 1999
HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVO
K991513
I-Flow Corp.
General Hospital · 52d
Cleared Jun 15, 1999
CADD ADMINISTRATION SET
K991599
Sims Deltec, Inc.
General Hospital · 36d
Cleared Jun 09, 1999
CADD-TPN ADMINISTRATION SET, MODEL 21-7071
K991255
Sims Deltec, Inc.
General Hospital · 57d
Cleared Jun 09, 1999
CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPHON VALVE, CADD ADMINISTRATION SET WITH 1
K991301
Sims Deltec, Inc.
General Hospital · 54d
Cleared May 14, 1999
FLEXNEEDLE PLUS
K990693
Act Medical, Inc.
General Hospital · 72d
Cleared Mar 29, 1999
TUTOPLUS IV ADMINISTRATION SET
K990388
Myco Medical Supplies, Inc.
General Hospital · 49d
Cleared Mar 01, 1999
TUTODROP 1 AND TUTODROP 2
K982098
Myco Medical Supplies, Inc.
General Hospital · 259d
Cleared Feb 24, 1999
FREE FLOW SAFETY DEVICE, MODEL MG 245052
K990288
Teva Medical, Ltd.
General Hospital · 26d
Cleared Feb 22, 1999
KVO CHECK VALVE ACCESSORY, MODEL EV-0001
K984441
I-Flow Corp.
General Hospital · 70d
Cleared Feb 19, 1999
BURETROL SOLUTION SETS
K984381
Baxter Healthcare Corp
General Hospital · 73d
Cleared Feb 12, 1999
CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER
K990083
Sims Deltec, Inc.
General Hospital · 32d
Cleared Feb 09, 1999
COLORVEES IV SET 20 DROPS/ML 105, 60 DROPS/ML 105, VENTED 20 DROPS 105, VENTED 60 DROPS 105
K983411
Valnet Medical Corp.
General Hospital · 134d
Cleared Feb 09, 1999
PARAGON BASAL/BOLUS ADMINISTRATION SET
K984063
I-Flow Corp.
General Hospital · 85d
Cleared Feb 09, 1999
PARAGON INFUSION
K984146
I-Flow Corp.
General Hospital · 82d
Cleared Feb 09, 1999
PARAGON BOLUS ACCESSORY SET
K984638
I-Flow Corp.
General Hospital · 40d