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
361–384 of 1176
Cleared Feb 04, 1999
SUBCUTANEOUS INFUSION SETS, MSR MODEL A & B
K984561
Msr, Inc.
General Hospital · 43d
Cleared Jan 20, 1999
ROWE DUAL-CHECK VALVE
K983217
Cook, Inc.
General Hospital · 128d
Cleared Jan 20, 1999
MPS GRAVITY FLOW CONTROL SET
K983926
Critical Device Corp.
General Hospital · 76d
Cleared Dec 16, 1998
I.V. EXTENSION SET OR I.V. ADMINISTRATION SET
K983073
Integra Biotechnical, LLC
General Hospital · 105d
Cleared Sep 04, 1998
COLLEAGUE PUMP SYRINGE ADAPTER SET
K982672
Baxter Healthcare Corp
General Hospital · 35d
Cleared Aug 24, 1998
MPS FIXED FLOW RATE SET
K982587
Medical Product Specialists
General Hospital · 31d
Cleared Aug 17, 1998
SOLUTION ADMINISTRATION SET
K981792
Baxter Healthcare Corp
General Hospital · 88d
Cleared Jul 28, 1998
HUBER NEEDLE INFUSION SET MODEL #20G01 & Y-SITE MODEL #20G01Y
K981683
Venusa , Ltd.
General Hospital · 76d
Cleared Jul 21, 1998
MPS HUBER NEEDLE EXTENSION SET
K982047
Medical Product Specialists
General Hospital · 41d
Cleared Jul 21, 1998
CONTRAST CONTROL DEVICE
K982123
Medex, Inc.
General Hospital · 35d
Cleared Jun 29, 1998
MANAN BLUNT NEEDLE
K981386
Manan Medical Products, Inc.
General Hospital · 74d
Cleared Jun 18, 1998
NFC NEEDLEFREE Y-SITE, MODEL 69970
K981547
Filtertek, Inc.
General Hospital · 49d
Cleared Jun 18, 1998
NFC NEEDLEFREE CONNECTOR MODEL 69900
K981548
Filtertek, Inc.
General Hospital · 49d
Cleared Jun 16, 1998
STABLE FLOW
K981157
Cmed
General Hospital · 77d
Cleared May 29, 1998
IV ADMINISTRATION SETS WITH NEEDLE ACCESS DEVICES
K980994
Venetec Intl., Inc.
General Hospital · 73d
Cleared May 28, 1998
IV ADMINISTRATION SETS WITH NEEDLELESS ACCESS DEVICES
K980992
Venetec Intl., Inc.
General Hospital · 72d
Cleared May 21, 1998
SOLUTION ADMINISTRATION SET WITH CAPPED LUER ACTIVATED VALVE
K974571
Baxter Healthcare Corp
General Hospital · 164d
Cleared Apr 27, 1998
EXTENSION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE CADD ADMINISTRATION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE
K980583
Sims Deltec, Inc.
General Hospital · 69d
Cleared Apr 22, 1998
DUAL LUER LOCK CAP
K981318
Baxter Healthcare Corp
General Hospital · 12d
Cleared Mar 11, 1998
6 INCH MINI-BONE EXTENSION SET WITH LUER LOCK, NES01S, 6 INCH MIN-BONE EXTENSION SET WITH LUER SLIP, NES02S, 6 INCH STAT
K980127
Catheter Innovations, Inc.
General Hospital · 56d
Cleared Mar 09, 1998
NP MEDICAL CAPLESS LUER ACTIVATED VALVE
K973916
Np Medical, Inc.
General Hospital · 146d
Cleared Feb 02, 1998
MINIMED SOF-SET ULTIMATE QR INFUSION SET MODELS 315 AND 316
K974163
Medtronic Minimed
General Hospital · 89d
Cleared Jan 23, 1998
MCKINLEY OUTBOUND-2 SYSTEM
K971844
Mckinley, Inc.
General Hospital · 249d
Cleared Jan 09, 1998
SMARTVALVE
K974589
Icu Medical, Inc.
General Hospital · 31d