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
433–456 of 1176
Cleared Sep 18, 1996
FLEX NEEDLE
K961049
Lighthouse Medical, Inc.
General Hospital · 187d
Cleared Sep 16, 1996
BIOMEDIX I.V. EXTENSION LINE W/ STOPCOCK MODEL B50-102/B51-102
K961928
Biomedix, Inc.
General Hospital · 122d
Cleared Sep 13, 1996
VENIPUNCTURE KIT
K963070
Miller Products and Services
General Hospital · 37d
Cleared Aug 28, 1996
SAFE MATE I.V. EXTENSION SETS
K962801
Biological & Environmental Control Laboratories
General Hospital · 41d
Cleared Aug 28, 1996
SAFE MATE I.V. FLUID DELIVERY SETS
K962802
Biological & Environmental Control Laboratories
General Hospital · 41d
Cleared Aug 01, 1996
FLUID ADMINISTRATION SET - CONTRAST MANAGER
K961794
Merit Medical Systems, Inc.
General Hospital · 84d
Cleared Jul 10, 1996
I.V. ADMINISTRATION SETS
K955821
Medical Associates Network, Inc.
General Hospital · 197d
Cleared Jul 03, 1996
STRATO/INFUSAID PERIPORT INFUSION SET 41770,41771
K960391
Strato/Infusaid, Inc.
General Hospital · 156d
Cleared Jun 26, 1996
HUBER NEEDLE EXTENSION SET WITH STANDARD Y-INJECTION SITE, INTERLINK Y-INJECTION SITE, INTERLINK T-INJECTION SITE
K961495
Baxter Healthcare Corp
General Hospital · 69d
Cleared Jun 21, 1996
CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SET
K961225
Baxter Healthcare Corp
General Hospital · 84d
Cleared May 29, 1996
ENERGIZED CONTAINER SYSTEM (MODIFICATION)
K954283
Abbott Laboratories
General Hospital · 267d
Cleared May 15, 1996
V2 INJECTION SITE
K955585
B.Braun Medical, Inc.
General Hospital · 160d
Cleared May 15, 1996
BEC NEEDLELESS INJECTION SITE
K961327
Biological & Environmental Control Laboratories
General Hospital · 37d
Cleared May 06, 1996
SNAPDOSE DEVICE
K955410
Abbott Laboratories
General Hospital · 161d
Cleared May 06, 1996
POLYFIN INFUSION SET MMT-106/MMT-107/MMT-133
K961474
Medtronic Minimed
General Hospital · 18d
Cleared Apr 23, 1996
FREE FLOW SAFETY DEVICE
K954883
Migada, Inc.
General Hospital · 186d
Cleared Apr 04, 1996
IVAC NEEDLE FREE VALVE ADMINISTRATION SETS
K960280
Y
General Hospital · 76d
Cleared Mar 21, 1996
MAXCESS NEEDLE FREE CONNECTOR (8200)
K960661
Solopak Medical Products, Inc.
General Hospital · 34d
Cleared Feb 26, 1996
ANGIOFLUSH II FLUID MANAGEMENT SYSTEM
K953825
AngioDynamics, Inc.
General Hospital · 195d
Cleared Feb 22, 1996
POLYFIN QR SUBCUTANEOUS INFUSION SET
K954969
Medtronic Minimed
General Hospital · 115d
Cleared Feb 21, 1996
WINGED & SUBCUTANEOUS INFUSION SETS
K955709
Distronic Sterile Products, Inc.
General Hospital · 65d
Cleared Feb 21, 1996
VENTED SOLUTION SET
K955732
Distronic Sterile Products, Inc.
General Hospital · 64d
Cleared Feb 16, 1996
NIMA (NEEDLELESS INJECTIONSITE MASTER ADAPTER) & I.V. SET
K952852
Critical Device Corp.
General Hospital · 240d
Cleared Feb 07, 1996
VLV SA.EF INFUSION PORT EXTENSION SETS
K955783
Vlv Associates, Inc.
General Hospital · 48d