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
385–408 of 1176
Cleared Jan 06, 1998
V3 VALVE
K974145
B.Braun Medical, Inc.
General Hospital · 64d
Cleared Dec 17, 1997
PROTOS 100ML BURETTE INFUSION SET/ PROTOS 150ML BURETTE INFUSION SET
K972839
Globe Ent., Inc.
General Hospital · 138d
Cleared Dec 17, 1997
PROTOS I.V. ADMINISTRATION SET (15 DROPS/ML) I4070S/(60 DROPS/ML)I4670S PRELIMINARY
K972854
Globe Ent., Inc.
General Hospital · 138d
Cleared Dec 17, 1997
EXTENSION SET WITH MICROBORE TUBING, EXTENSION SET WITH MICROBORE TUBING AND 0.2 U FILTER, EXTENSION SET WITH MICROBORE
K974013
Sims Deltec, Inc.
General Hospital · 56d
Cleared Dec 16, 1997
EXEL I.V. ADMINISTRATION SET
K963659
Exel Intl.
General Hospital · 469d
Cleared Nov 17, 1997
POSITIVE PRESSURE CONNECTOR
K973167
Icu Medical, Inc.
General Hospital · 84d
Cleared Oct 02, 1997
MEDCORP FLOW I.V. REGULATOR EXTENSION SET
K971004
Medcorp Intl.
General Hospital · 197d
Cleared Oct 02, 1997
AMSINO I.V. ADMINISTRATION SET
K973107
Amsino Intl., Inc.
General Hospital · 44d
Cleared Oct 01, 1997
CORE RESISTANT HUBER INFUSION SETS
K972712
Icu Medical, Inc.
General Hospital · 72d
Cleared Sep 29, 1997
SA-EF MULTI-LUMEN EXTENSION SET
K972957
Vlv Associates, Inc.
General Hospital · 49d
Cleared Sep 18, 1997
NIPRO DISPOSABLE SOLUTION INFUSION SET
K972493
Nipro Medical Corp.
General Hospital · 77d
Cleared Sep 18, 1997
PHASEAL, SYSTEM FOR SEALED HANDLING OF CHEMOTHERAPEUTIC AGENTS
K972527
Quality System Consulting
General Hospital · 73d
Cleared Sep 08, 1997
DYE STOP AND SAVE - QUICKFILL
K971624
Shepherd Laboratories, Inc.
General Hospital · 129d
Cleared Sep 02, 1997
SMART SET
K972663
Top Spins, Inc.
General Hospital · 56d
Cleared Aug 26, 1997
MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SET
K972135
P/L Biomedical
General Hospital · 81d
Cleared Aug 18, 1997
ACCESS SYSTEMS NEEDLELESS VIAL ADAPTER
K971500
Biological & Environmental Control Laboratories
General Hospital · 116d
Cleared Jul 16, 1997
NEEDLE-FREE VALVED CONNECTOR AND CAP
K964439
Bmw Medical, Inc.
General Hospital · 252d
Cleared Jun 27, 1997
LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE
K971293
Abbott Mfg., Inc.
General Hospital · 81d
Cleared Jun 24, 1997
VENTED I.V. SET
K965027
Jms Co., Ltd.
General Hospital · 189d
Cleared Jun 24, 1997
CLAVE CONNECTOR
K970855
Icu Medical, Inc.
General Hospital · 106d
Cleared Jun 06, 1997
CONTINU-FLO SOLUTION SET
K971701
Baxter Healthcare Corp
General Hospital · 29d
Cleared Jun 05, 1997
GORE IRRIGATION SET
K964067
W.L. Gore & Associates, Inc.
General Hospital · 238d
Cleared Jun 04, 1997
TAMARYN I.V. FLOW REGULATOR EXTENSION SET
K971066
Tamaryn Medical Systems, Inc.
General Hospital · 72d
Cleared May 06, 1997
SAFE-CONNECT I.V. SET
K970909
Faulding Medical Device Co.
General Hospital · 55d