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
313–336 of 1176
Cleared Mar 15, 2001
SURSHIELD WINGED INFUSION SET
K010103
Terumo Medical Corp.
General Hospital · 62d
Cleared Mar 13, 2001
SIMPLICITY SOFT Y INFUSION SET FOR USE WITH THE MINIMED INFUSION PUMPS AND MINIMED MEDICATION RESERVOIRS (MODEL MMT-103)
K010373
Sterling Medivations, Inc.
General Hospital · 34d
Cleared Mar 06, 2001
SWABSITE SWABBABLE VALVE, MODEL 245000
K002689
Quest Medical, Inc.
General Hospital · 189d
Cleared Jan 11, 2001
TAXOL ADMINISTRATION SET
K003513
Icu Medical, Inc.
General Hospital · 58d
Cleared Dec 13, 2000
SIMPLICITY WITH WINGS INFUSION SET, (MODEL MMT-103)
K003283
Sterling Medivations, Inc.
General Hospital · 55d
Cleared Oct 24, 2000
SIMPLICITY SOFT INFUSION SET
K002492
Sterling Medivations, Inc.
General Hospital · 71d
Cleared Oct 19, 2000
SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE
K003225
Baxter Healthcare Corp
General Hospital · 3d
Cleared Aug 10, 2000
LIFESHIELD ADDITIVE PIERCING PIN
K002006
Abbott Laboratories
General Hospital · 38d
Cleared May 31, 2000
SURGEN VALVE
K990331
Tiva Medical
General Hospital · 484d
Cleared May 10, 2000
POSI-LINK
K000472
Icu Medical, Inc.
General Hospital · 86d
Cleared Apr 27, 2000
CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090
K000942
Sims Deltec, Inc.
General Hospital · 35d
Cleared Mar 03, 2000
VENUSA, LTD. EXTENSION SET WITH FILTER
K994429
Venusa , Ltd.
General Hospital · 64d
Cleared Feb 23, 2000
EXEL INJECTION PLUG WITH CAP
K992290
Exel Intl.
General Hospital · 231d
Cleared Jan 27, 2000
MILLENNIUM HUBER PLUS SAFETY INFUSION SET
K993848
Millennium Medical Distribution, Inc.
General Hospital · 76d
Cleared Jan 04, 2000
INTRAVASCULAR ADMINISTRATION SET
K993463
Custom Assemblies, Inc.
General Hospital · 83d
Cleared Nov 05, 1999
DAISY PROTECTED SCALP VEIN SET
K992999
Diasol, Inc.
General Hospital · 59d
Cleared Nov 05, 1999
SHELLY PROTECTED AV FISTULA NEEDLE
K993187
Diasol, Inc.
General Hospital · 43d
Cleared Nov 02, 1999
DECAP
K993147
The Kipp Group
General Hospital · 42d
Cleared Oct 27, 1999
IV ADMINISTRATION SET
K992266
New Alliance of Independent Medical Distributors,
General Hospital · 113d
Cleared Oct 14, 1999
ECOMED SCALP VEIN SET
K992145
Greiner Meditech, Inc.
General Hospital · 112d
Cleared Sep 15, 1999
BOLUS ACCESSORY SET
K992072
I-Flow Corp.
General Hospital · 88d
Cleared Sep 15, 1999
NAC PRN NEEDLELESS ACCESS CONNECTOR
K992268
The Kipp Group
General Hospital · 71d
Cleared Sep 03, 1999
SOF-SET MICRO QR INFUSION SET, MODELS 320 AND 321
K991979
Medtronic Minimed
General Hospital · 81d
Cleared Sep 02, 1999
SAGE CONTRAST MANAGEMENT SYSTEM
K991112
Sage Laboratories, Inc.
General Hospital · 154d