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 Corporation, B.Braun Medical, Inc. and Quest Medical, Inc..

23
Total
23
Cleared
216d
Avg days
2021
Since

List of Set, Administration, Intravascular devices cleared through 510(k)

23 devices
1–23 of 23
Cleared Aug 29, 2025
EZ™ IV Administration Set
K251814
Epic Medical Pte. , Ltd.
General Hospital · 77d
Cleared Jul 24, 2025
Infusomat® Space Volumetric Infusion Pump Administration Sets
K243392
B.Braun Medical, Inc.
General Hospital · 266d
Cleared Jun 05, 2025
Clave™ Neutral-Displacement Needlefree Connectors
K250616
Icu Medical, Inc.
General Hospital · 97d
Cleared May 02, 2025
JetCan® Pro Safety Huber Needle
K242763
Pfm Medical, Inc.
General Hospital · 232d
Cleared Mar 14, 2025
Solution Administration Sets
K243529
Baxter Healthcare Corporation
General Hospital · 120d
Cleared Feb 28, 2025
Intravascular Extension Sets and Accessories
K242339
Baxter Healthcare Corporation
General Hospital · 205d
Cleared Dec 18, 2024
Lyka® PORT Needle Free Access Device (4170Y)
K241058
Quest Medical, Inc.
General Hospital · 244d
Cleared Nov 03, 2023
ProSeal™ Closed System Administration Set
K230343
Epic Medical Pte. , Ltd.
General Hospital · 268d
Cleared Jul 21, 2023
BD Alaris™ Pump Infusion Sets
K221327
Care Fusion
General Hospital · 441d
Cleared May 12, 2023
BD Secondary Infusion Set
K223101
Care Fusion
General Hospital · 224d
Cleared Apr 07, 2023
BD SmartSite™ Needle-Free Connector
K223088
Care Fusion
General Hospital · 189d
Cleared Oct 07, 2022
AMSafe NeuFlo Needleless Connector
K220267
Amsino International, Inc.
General Hospital · 249d
Cleared Oct 03, 2022
PCA Syringe Sets
K212262
Baxter Healthcare Corporation
General Hospital · 440d
Cleared Jun 05, 2022
Q2 Blood Administration Sets
K213846
Quest Medical, Inc.
General Hospital · 177d
Cleared Jun 02, 2022
Q2 IV Administration Sets
K213588
Quest Medical, Inc.
General Hospital · 202d
Cleared Mar 03, 2022
IV Administration Set
K213778
B.Braun Medical, Inc.
General Hospital · 90d
Cleared Jan 18, 2022
Microvolume Luer Access Device
K212842
B.Braun Medical, Inc.
General Hospital · 133d
Cleared Sep 30, 2021
Intravascular Administration Sets
K203609
Baxter Healthcare Corporation
General Hospital · 294d
Cleared Sep 24, 2021
IV Administration Sets
K202618
B.Braun Medical, Inc.
General Hospital · 379d
Cleared Jun 18, 2021
Intravascular Extension Set
K210430
Baxter Healthcare Corporation
General Hospital · 126d
Cleared May 17, 2021
Needleless Connector
K210217
Jiangsu Caina Medical Co.,Ltd
General Hospital · 110d
Cleared Mar 24, 2021
Safety Subcutaneous Infusion Set
K201626
Epic Medical Pte. , Ltd.
General Hospital · 281d
Cleared Jan 21, 2021
Precision Delivery Infusion Set
K202672
Quest Medical, Inc.
General Hospital · 128d

How to use this database

This page lists all FDA 510(k) submissions for Set, Administration, Intravascular devices (product code FPA). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the General Hospital FDA review panel. Browse all General Hospital devices →