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
457–480 of 1176
Cleared Jan 30, 1996
VENIPUNCTURE KIT
K954823
Winfield Industries
General Hospital · 102d
Cleared Jan 26, 1996
ARROW HIGH FLOW FLUID ADMINSITRATION SET W/BLOOD FILTER & EXTENSION SET
K953746
Arrow Intl., Inc.
General Hospital · 169d
Cleared Jan 23, 1996
I.V. ADMINISTRATION SET CONNECTING DEVICE
K940832
Sierra Medical Devices
General Hospital · 699d
Cleared Jan 23, 1996
EXTENSION SET WITH CHECK VALVE
K954983
Distronic Sterile Products, Inc.
General Hospital · 84d
Cleared Dec 15, 1995
SIMS DELTEC ANTI-SIPHON VALVE
K954870
Sims Deltec, Inc.
General Hospital · 52d
Cleared Nov 29, 1995
ICU EXTENSION KIT
K954813
Icu Medical, Inc.
General Hospital · 41d
Cleared Nov 21, 1995
LOW PROFILE SAFSITE Y-SITE
K954123
B.Braun Medical, Inc.
General Hospital · 81d
Cleared Oct 24, 1995
LIFESHIELD LUER ACTIVATED VALVE MALE ADAPTER PLUG
K953584
Abbott Laboratories
General Hospital · 84d
Cleared Sep 27, 1995
IVAC BALL VALCE ADMIN. SETS
K953225
Y
General Hospital · 79d
Cleared Sep 21, 1995
INTRAVASCULAR (I-V) ADMININISTRATION SET (DVGENPERS FPA)
K952160
Medex, Inc.
General Hospital · 136d
Cleared Sep 15, 1995
PLASTIC BLUNT CANNULA
K952976
Marquette Medical, Inc.
General Hospital · 80d
Cleared Aug 24, 1995
VENTED/NONVENTED GEMINI ADMINISTRATION SET WITH CHECK VALVE AND TWO SAFSITE(TM) VALVES
K950153
Imed Corp.
General Hospital · 219d
Cleared Aug 18, 1995
FIXED FLOW RATE GRAVITY ADMINISTRATION SETS
K952760
I-Flow Corp.
General Hospital · 63d
Cleared Jul 27, 1995
SOLUTION SET WITH 1.2 MICRON AIR ELIMINATING FILTER
K952074
Baxter Healthcare Corp
General Hospital · 86d
Cleared Jul 19, 1995
ADMINISTRATION SETS WITH BALL FLOAT
K951922
Imed Corp.
General Hospital · 86d
Cleared Jul 14, 1995
FILTERED EXTENSION SETS
K942988
B. Braun of America, Inc.
General Hospital · 389d
Cleared Jun 14, 1995
SMARTFLOW I ADMINISTRATION SET
K945298
River Medical, Inc.
General Hospital · 226d
Cleared May 31, 1995
E-Z SET, SAF-T E-Z SET, AND MINICATH INFUSION SETS
K952053
Becton Dickinson Vascular Access, Inc.
General Hospital · 30d
Cleared Apr 10, 1995
LOW VOLUME MULTIPORT
K943770
B. Braun of America, Inc.
General Hospital · 251d
Cleared Mar 14, 1995
DESERET(R) I.V. LOOP AND DESERET (R) J LOOP
K950303
Becton Dickinson Vascular Access, Inc.
General Hospital · 48d
Cleared Mar 14, 1995
DESERET (R) T-PORT (R) MULTI FLO(TM) AND DESERET (R)PRN ADAPTER
K950304
Becton Dickinson Vascular Access, Inc.
General Hospital · 48d
Cleared Mar 13, 1995
E-Z SET(R) AND MINICATH(R) INFUSION SETS
K950302
Becton Dickinson Vascular Access, Inc.
General Hospital · 47d
Cleared Feb 14, 1995
VENTED/NON-VENTED GEMINI ADMINISTRATION SET
K944320
Imed Corp.
General Hospital · 169d
Cleared Feb 10, 1995
NU-SITE
K943897
Medex, Inc.
General Hospital · 184d