ClearanceBrief
Panels › General Hospital › Product code FPA · Class 2

Set, Administration, Intravascular

Regulation 880.5440

6510(k)s in 12 months (1,176 all time)
110recalls in 12 months (1,090 all time)
1,030recalls that name a 510(k)
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Top companies in FPA

Company510(k)sRecalls
B.Braun Medical, Inc.23234
Baxter Healthcare Corp67151
Icu Medical, Inc.27187
Hospira, Inc.14109
Smiths Medical MD, Inc.437
Churchill Medical Systems, Inc.732
CME America, LLC038
Abbott Laboratories300
Y280
Carefusion, Inc.125
Decided510(k)Device and applicantCode
Oct 22, 2026K260261Gravity Blood Sets with 200µm Filter
B.Braun Medical, Inc.
FPA
Sep 11, 2026K254123Ecomed Disposable Administration Sets
Ecomed Solutions, LLC
FPA
Jun 3, 2026K261530iiSure Infusion Set
Deka Research and Development
FPA
May 4, 2026K252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-12
Amsino International, Inc.
FPA
Feb 12, 2026K251375PuraCath Firefly Needleless Connector IT (9005)
Puracath Medical, Inc.
FPA
Dec 4, 2025K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needl
Np Medical
FPA
Oct 30, 2025K250325BD Alaris Pump Infusion Set
Carefusion (Bd)
FPA
Aug 29, 2025K251814EZ™ IV Administration Set
Epic Medical Pte. , Ltd., SG
FPA
Aug 6, 2025K251854SteadiSet infusion set
Tandem Diabetes Care
FPA
Aug 1, 2025K243841Sparta Infusion Set for Insulin
Deka Research and Development
FPA
Jul 24, 2025K243392Infusomat® Space Volumetric Infusion Pump Administration Sets
B.Braun Medical, Inc.
FPA
Jun 5, 2025K250616Clave™ Neutral-Displacement Needlefree Connectors
Icu Medical, Inc.
FPA
May 9, 2025K242692SteadiSet Infusion Set
Capillary Biomedical, LLC
FPA
May 2, 2025K242763JetCan® Pro Safety Huber Needle
Pfm Medical, Inc.
FPA
Mar 14, 2025K243529Solution Administration Sets
Baxter Healthcare Corporation
FPA
Feb 28, 2025K242339Intravascular Extension Sets and Accessories
Baxter Healthcare Corporation
FPA
Dec 18, 2024K241058Lyka® PORT Needle Free Access Device (4170Y)
Quest Medical, Inc.
FPA
Sep 20, 2024K234129Ecomed Disposable Administration Sets
Ecomed Solutions, LLC
FPA
Aug 22, 2024K242126I.V. Administration Set
Bq Plus Medical Co., Ltd., CN
FPA
May 10, 2024K232475Disposable infusion set with needle
Shandong Zhushi Pharmaceutical Group Co., Ltd., CN
FPA
Apr 12, 2024K222766Disposable Extension Set
Shandong Ande Healthcare Apparatus Co., Ltd., CN
FPA
Mar 1, 2024K232328Insignis™ Syringe Infusion System
Innovative Health Sciences, LLC
FPA
Jan 3, 2024K231707ResQ Administration Set
Q For Plastic Industries, EG
FPA
Dec 1, 2023K230528Extension Set
Medcaptain Life Science Co., Ltd., CN
FPA
Nov 9, 2023K222780LILY Extension Tube and Needleless Connector
Lily Medical Corporation, CN
FPA
Nov 3, 2023K230343ProSeal™ Closed System Administration Set
Epic Medical Pte. , Ltd., SG
FPA
Jul 21, 2023K221327BD Alaris™ Pump Infusion Sets
Care Fusion
FPA
Jun 23, 2023K221411Surflo Winged Infusion Set
Terumo Medical Products (Hangzhou) Co., Ltd., CN
FPA
Jun 16, 2023K221121Volumat Polyethylene I.V. Administration Set
Fresenius Kabi, DE
FPA
Jun 9, 2023K230992DJF Intravascular Administration Set
Yangzhou Wei DE LI Trade Co., Ltd., CN
FPA
Jun 2, 2023K220301Volumat Line
Fresenius Kabi, DE
FPA
May 18, 2023K223645I.V. Administration Set, I.V. Extension Set
Bq Plus Medical Co., Ltd., CN
FPA
May 12, 2023K223101BD Secondary Infusion Set
Care Fusion
FPA
Apr 19, 2023K220288NP Medical nPulse K150 Neutral Displacement Needle Free Connector, nPulse Neutral displacement needle free connector, nP
Np Medical, Inc.
FPA
Apr 12, 2023K220312Polyfusion IV Administration Sets
Poly Medicure Limited, IN
FPA
Apr 7, 2023K223088BD SmartSite™ Needle-Free Connector
Care Fusion
FPA
Jan 20, 2023K222889FlowArt® Needle-Free Split Septum Valve
Asset Medikal Tasarim San Tic As., TR
FPA
Nov 21, 2022K221078Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use
Sichuan Prius Biotechnology Co., Ltd., CN
FPA
Nov 21, 2022K221075Infusion Sets for Single Use
Sichuan Prius Biotechnology Co., Ltd., CN
FPA
Nov 21, 2022K221069Infusion Sets for Single Use with Needles
Sichuan Prius Biotechnology Co., Ltd., CN
FPA
Nov 3, 2022K221518NP Medical nCompass Extension Set with Stabilizing Base
Np Medical
FPA
Oct 7, 2022K220267AMSafe NeuFlo Needleless Connector
Amsino International, Inc.
FPA
Oct 3, 2022K212262PCA Syringe Sets
Baxter Healthcare Corporation
FPA
Sep 26, 2022K221473Flowart
Asset Medikal Tasarim As., TR
FPA
Sep 23, 2022K221481NeutrArt
Asset Medikal Tasarim As., TR
FPA
Jun 5, 2022K213846Q2 Blood Administration Sets
Quest Medical, Inc.
FPA
Jun 2, 2022K213588Q2 IV Administration Sets
Quest Medical, Inc.
FPA
May 10, 2022K213004Needle Free Connector
Medcaptain Life Science Co., Ltd., CN
FPA
Mar 25, 2022K202437Infusion Sets for Single Use
Jiangsu Suyun Medical Materials Co., Ltd., CN
FPA
Mar 3, 2022K213778IV Administration Set
B.Braun Medical, Inc.
FPA

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