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
505–528 of 1176
Cleared Mar 23, 1994
EXTENSION TUBE, EXTENSION TUBE LENGTH 20, & 30
K940073
Puritas Health Care, Inc.
General Hospital · 76d
Cleared Feb 22, 1994
SAFE CONNECTOR
K940296
Icu Medical, Inc.
General Hospital · 32d
Cleared Feb 09, 1994
REMOTE RESERVOIR ADAPTER(TM) CASSETTE WITH BAG
K933390
Pharmacia Deltec, Inc.
General Hospital · 212d
Cleared Jan 21, 1994
0.22 MICRON FINAL FILTER WITH EXTENSION TUBE
K935601
Puritas Health Care, Inc.
General Hospital · 63d
Cleared Jan 14, 1994
SOLUTION SET WITH .2 MICRON FILTER
K930854
Douglas Medical Products Corp.
General Hospital · 330d
Cleared Jan 10, 1994
EZ ADMINISTRATION SET
K931550
Y
General Hospital · 287d
Cleared Jan 07, 1994
3 LEAD CONNECTOR
K931659
Douglas Medical Products Corp.
General Hospital · 277d
Cleared Jan 07, 1994
SUBCUTANEOUS INFUSION SET
K932637
Douglas Medical Products Corp.
General Hospital · 219d
Cleared Dec 21, 1993
IN-LINE BURETTE SET
K931658
Douglas Medical Products Corp.
General Hospital · 260d
Cleared Dec 14, 1993
HUBER NEEDLE INFUSION SET
K932638
Douglas Medical Products Corp.
General Hospital · 195d
Cleared Nov 29, 1993
INJECTION SITE
K932446
3M Health Care, Ltd.
General Hospital · 193d
Cleared Nov 03, 1993
ENERGIZED CONTAINER SYSTEM
K925418
Abbott Laboratories
General Hospital · 372d
Cleared Oct 14, 1993
AVI MODEL 4225 VENTED PIGGYBACK IV ADMIN SET
K912069
3M Avi, Inc.
General Hospital · 888d
Cleared Oct 12, 1993
IVAC NEEDLELESS INJECTION VALVE
K922115
Y
General Hospital · 525d
Cleared Sep 03, 1993
DURHAM
K930406
Intl. Medical, Inc.
General Hospital · 220d
Cleared Sep 03, 1993
DURHAM
K930410
Intl. Medical, Inc.
General Hospital · 220d
Cleared Aug 28, 1993
SUB-Q-SET(R) SUBCUTANEOUS INFUSION SET
K925362
Baxter Healthcare Corp
General Hospital · 310d
Cleared Aug 11, 1993
EXEL HUBER INFUSION SET ROTATING WING
K926119
Exel Intl.
General Hospital · 251d
Cleared Aug 03, 1993
BARD AMBU PUMP SPIK TUB SET PACRET PROVID PUMP SET
K925058
C.R. Bard, Inc.
General Hospital · 301d
Cleared Aug 03, 1993
LO-PROFILE EXTENSIONSET W/ .22 MICRON FILTER
K925430
Douglas Medical Products Corp.
General Hospital · 280d
Cleared Jul 30, 1993
IVAC 59 SERIES UNIVERSAL SET W/ ANTI-FREE FLOW VAL
K925228
Y
General Hospital · 287d
Cleared Jul 30, 1993
REPLACEMENT CAP
K930855
Douglas Medical Products Corp.
General Hospital · 162d
Cleared Jul 27, 1993
DOUGLAS MEDICAL PRODUCTS, INC. VENTED SPIKE ADAPT
K926184
Douglas Medical Products Corp.
General Hospital · 231d
Cleared Jul 20, 1993
BAXTER SOLUTION ADMINISTRATION SETS
K924721
Baxter Healthcare Corp
General Hospital · 302d