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
265–288 of 1176
Cleared Jul 28, 2004
PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION, MODEL 5118
K041410
Icu Medical, Inc.
General Hospital · 62d
Cleared Jul 16, 2004
SPLIT SEPTUM INJECTION SITES
K041042
Fresenius Medical Care North America
General Hospital · 85d
Cleared Jun 30, 2004
CONTACT DETACH
K041545
Unomedical A/S
General Hospital · 21d
Cleared Jun 04, 2004
MODIFICATION TO THE NAC PLUS NEEDLELESS ACCESS CONNECTOR
K041179
Medegen Medical Manufacturing Services, Inc.
General Hospital · 29d
Cleared May 19, 2004
CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FLOW STOP AND EXTENSION SET
K040636
Smiths Medical MD, Inc.
General Hospital · 70d
Cleared Apr 12, 2004
TALON INFUSION SET, MODEL IP XXXX
K033290
Icu Medical, Inc.
General Hospital · 181d
Cleared Apr 07, 2004
MULTIPORT MANIFOLD SET WITH SWABABLE VALVES, MODEL 9900
K040385
Quest Medical, Inc.
General Hospital · 50d
Cleared Dec 04, 2003
CLC2000 CATHETER PATENCY DEVICE
K021692
Icu Medical, Inc.
General Hospital · 561d
Cleared Dec 04, 2003
LIFESHIELD LATEX-FREE PRIMARY IV PUMP SET DISTAL MICROBORE PATIENT LINE, CONVERTIBLE PIN, 72 INCH, WITH 2 PRESSURE
K033576
Abbott Laboratories
General Hospital · 21d
Cleared Nov 18, 2003
BD VACUTAINER SAFETY-LOK ADMINISTRATION SET WITH FILTER
K033350
Becton, Dickinson & CO
General Hospital · 29d
Cleared Oct 28, 2003
MEDTRONIC MINIMED PARADIGM COUNTACH INFUSION SET, MODEL MMT 310
K032484
Medtronic Minimed
General Hospital · 77d
Cleared Oct 28, 2003
MEDTRONIC MINIMED COUNTACH INFUSION SET, MODEL 313
K032485
Medtronic Minimed
General Hospital · 77d
Cleared Sep 08, 2003
MARQUETTE HUBER TRAP SAFETY INFUSION SET
K021471
Marquette Medical, Inc.
General Hospital · 488d
Cleared Aug 19, 2003
MEDTRONIC MINIMED PARADIGM POLYFIN QR, MODEL MMT 312L AND 312S
K031917
Medtronic Minimed
General Hospital · 57d
Cleared Aug 11, 2003
ULTRASITE VALVE
K031923
B.Braun Medical, Inc.
General Hospital · 49d
Cleared May 30, 2003
SURSHIELD SAFETY WINGED INFUSION SET
K031266
Terumo Corp.
General Hospital · 39d
Cleared Feb 19, 2003
NEXUS INJECTION SITE (NIS), MODEL NIS-1
K024363
Nexus Medical, LLC
General Hospital · 50d
Cleared Jan 27, 2003
LIFESHIELD PRIMARY IV SET CONV. PIN. CLAVE
K030002
Abbott Laboratories
General Hospital · 25d
Cleared Aug 06, 2002
ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS
K022209
Alaris Medical Systems, Inc.
General Hospital · 29d
Cleared Jul 08, 2002
SURECAN SAFETY HUBER NEEDLE INFUSION SETS
K021488
B.Braun Medical, Inc.
General Hospital · 61d
Cleared May 21, 2002
SIMPLICITY EASY P SOFT INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE OF THE SKIN
K021530
Sterling Medivations, Inc.
General Hospital · 11d
Cleared May 17, 2002
SIMPLICITY EASY ACCESS P INFUSION SET
K021487
Sterling Medivations, Inc.
General Hospital · 9d
Cleared May 14, 2002
SIMPLICITY QD EASY P INFUSION SET
K021296
Sterling Medivations, Inc.
General Hospital · 20d
Cleared May 03, 2002
SIMPLICTY SIMPLEX P INFUSION SET FOR USE WITH THE MINIMED PARADIGM INFUSION PUMPS
K021216
Sterling Medivations, Inc.
General Hospital · 16d