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
601–624 of 1176
Cleared Jul 18, 1988
LUER-LOK MULTIFLO ADAPTER
K882797
Deseret Medical, Inc.
General Hospital · 12d
Cleared Jul 18, 1988
MULTIFLO ADAPTER
K882798
Deseret Medical, Inc.
General Hospital · 12d
Cleared Jul 12, 1988
IVAC(R) UNVENTED VOL. INFUSION SET MODEL 52080
K882302
Y
General Hospital · 40d
Cleared Jun 20, 1988
EXTENDED LIFE INJECTION SITE
K882007
Baxter Healthcare Corp
General Hospital · 38d
Cleared Jun 16, 1988
BLOOD/SOLUTION SET W/PRESSURE PUMP
K881321
Baxter Healthcare Corp
General Hospital · 79d
Cleared Jun 13, 1988
VENOVALVE(TM)
K881234
Abbott Laboratories
General Hospital · 84d
Cleared May 26, 1988
CHECK VALVE
K881052
Baxter Healthcare Corp
General Hospital · 76d
Cleared Apr 29, 1988
MARQUETTE MEDICAL, INC. IV EXTENSION SETS
K880928
Marquette Medical, Inc.
General Hospital · 56d
Cleared Apr 01, 1988
SITE SOLUTION ADMINISTRATION SET
K874725
Site Microsurgical Systems, Inc.
General Hospital · 135d
Cleared Mar 18, 1988
SECONDARY SOLUTION ADMINISTRATION SET W/SHEATH
K880482
Baxter Healthcare Corp
General Hospital · 42d
Cleared Jan 29, 1988
MODEL DMC-75 MINI-CATHETER SET
K874307
Life-Tech Intl., Inc.
General Hospital · 101d
Cleared Jan 19, 1988
IVAC(R) DUAL RATE ADAPTER - MODEL 70090
K874581
Y
General Hospital · 71d
Cleared Jan 14, 1988
MX710 SERIES VASCULAR ACCESS INFUSION SET
K874133
Medex, Inc.
General Hospital · 93d
Cleared Dec 29, 1987
RATE-MATE NITROGLYCERIN I.V. ADMINISTRATION SET
K873729
Critikon Company, LLC
General Hospital · 105d
Cleared Dec 29, 1987
A SERIES OF 7 INCH CONTINUOUS INFUSION SETS
K874403
Quinton, Inc.
General Hospital · 62d
Cleared Nov 05, 1987
CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITE
K873894
Travenol Laboratories, S.A.
General Hospital · 42d
Cleared Nov 03, 1987
PHARMACIA DELTEC SUBCUTANEOUS INFUSION SET
K873885
Pharmacia Deltec, Inc.
General Hospital · 41d
Cleared Oct 23, 1987
MODEL 1330 EXTENSION SET
K873042
Pharmacia Deltec, Inc.
General Hospital · 80d
Cleared Oct 23, 1987
PHARMACIA DELTEC BAG SPIKE SET
K873876
Pharmacia Deltec, Inc.
General Hospital · 31d
Cleared Oct 22, 1987
LOOK FLUID DISTRIBUTION SET
K872945
Look, Inc.
General Hospital · 86d
Cleared Oct 13, 1987
CHURCHILL ALBUMIN IV ADMINISTRATION SET
K872124
Churchill Corp.
General Hospital · 134d
Cleared Oct 09, 1987
CHURCHILL TPN ADMINISTRATION SET
K872123
Churchill Corp.
General Hospital · 130d
Cleared Sep 04, 1987
CHANGE IN STERILITY TEST METHOD & TEST LAB. SITE
K872795
Medex, Inc.
General Hospital · 58d
Cleared Jun 25, 1987
THE GRIPPER(TM) PORT-A-CATH NEEDLES
K870866
Pharmacia, Inc.
General Hospital · 114d