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
409–432 of 1176
Cleared May 01, 1997
SAFE-CONNECT Y-SITE ADAPTER CATALOG NO. 681518
K971266
Faulding Medical Device Co.
General Hospital · 27d
Cleared Apr 22, 1997
SAFE-CONNECT I.V. EXTENSION SET
K970524
Faulding Medical Device Co.
General Hospital · 70d
Cleared Apr 21, 1997
SMARTSITE ACCESS PIN
K970485
Ivac Medical Systems
General Hospital · 70d
Cleared Apr 14, 1997
NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETS
K964918
Critical Device Corp.
General Hospital · 126d
Cleared Apr 14, 1997
KIPP MED I.V. MANIFOLD
K970255
The Kipp Group
General Hospital · 82d
Cleared Apr 08, 1997
E-Z SET INFUSION SET/SAF-T E-Z SET INFUSION SET
K970259
Becton Dickinson Vascular Access, Inc.
General Hospital · 75d
Cleared Apr 02, 1997
INTERLINK MICRO-INFUSION MANIFOLD EXTENSION SETS
K970438
Baxter Healthcare Corp
General Hospital · 56d
Cleared Apr 02, 1997
MAXCESS NEEDLEFREE - Y- SITE (100713)
K970800
Solopak Medical Products, Inc.
General Hospital · 29d
Cleared Mar 27, 1997
NIPRO DISPOSABLE SOLUTION INFUSION SET
K970076
Nipro Medical Corp.
General Hospital · 77d
Cleared Mar 24, 1997
CONMED: STAT 2 AND STAT 2 PUMPETTE EXTENSION SETS AND MASTERFLOW AND MASTERFLOW PUMPETTE PRIMARY SETS
K964844
Conmedcorp
General Hospital · 111d
Cleared Feb 28, 1997
SA.EF(TM) INFUSION PORT II - CONNECTOR AND EXTENSION SET
K964876
Vlv Associates, Inc.
General Hospital · 85d
Cleared Feb 27, 1997
MR EXTENSION SET (001)
K964968
University of Michigan
General Hospital · 77d
Cleared Feb 25, 1997
SOLUTION ADMINISTRATION SET WITH 0.22 MICRON HIGH PRESSURE EXTENDED LIFE FILTER
K964850
Baxter Healthcare Corp
General Hospital · 84d
Cleared Feb 14, 1997
VYGON BIONECTOR WITH EXTENSION SET
K963981
Vygon Corp.
General Hospital · 134d
Cleared Feb 10, 1997
NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER AND I.V. SET
K964812
Critical Device Corp.
General Hospital · 73d
Cleared Jan 30, 1997
POLYFIN WITH WINGS INFUSION SETS, MODELS 306, 307, 333
K964455
Medtronic Minimed
General Hospital · 85d
Cleared Jan 30, 1997
POLYFIN QR WITH WINGS INFUSION SETS, MODELS 365, 366, AND 367
K964456
Medtronic Minimed
General Hospital · 85d
Cleared Jan 27, 1997
MODEL D-290P ADMINISTRATION SET
K964384
Patient Solutions, Inc.
General Hospital · 84d
Cleared Dec 10, 1996
SLAV AND SLAV-ONE INJECTION PORT CONNECTOR SYSTEM
K960771
Rymed Technologies, Inc.
General Hospital · 288d
Cleared Nov 15, 1996
SAFECONNECT VALVE (CATALOG NO. XXXX)
K955775
Faulding Medical Device Co.
General Hospital · 330d
Cleared Nov 08, 1996
MMG MULTI LUMON EXTENSION SET
K963112
Mmg Healthcare, Inc.
General Hospital · 88d
Cleared Oct 29, 1996
PRESSURE STOPCOCK/MANIFOLD
K960431
Scientific Device Manufacturer, LLC
General Hospital · 272d
Cleared Oct 18, 1996
INTERLINK ADAPTER FOR CONVENTIONAL Y-SITE
K962893
Baxter Healthcare Corp
General Hospital · 85d
Cleared Oct 18, 1996
DELTEC SUBCUTANEOUS INFUSION SET
K963009
Sims Deltec, Inc.
General Hospital · 77d