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

Set, I.V. Fluid Transfer

Regulation 880.5440

2510(k)s in 12 months (206 all time)
1recalls in 12 months (65 all time)
54recalls that name a 510(k)
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Top companies in LHI

Company510(k)sRecalls
Baxter Healthcare Corp1226
Baxa Corp.317
B.Braun Medical, Inc.98
Medimop Medical Projects, Ltd.111
West Pharma. Services IL, Ltd.53
Yukon Medical80
Baxa Corp., Sub. of Cook Group, Inc.70
Carmel Pharma Ab.70
Laboratorios Grifols, S.A.70
Abbott Laboratories50
Decided510(k)Device and applicantCode
Jun 12, 2026K252987ADRx™ Admixture Device
Epic Medical Pte. , Ltd., SG
LHI
Jun 5, 2026K260301Vial Adapter
Hangzhou Qiantang Longyue Biotechnology Co., Ltd., CN
LHI
Oct 24, 2025K250345Medline Bag Decanter
Medline Industries, LP
LHI
Oct 14, 2025K251715FlowArt® Vial Access Device Vented
Asset Medikal, TR
LHI
Sep 16, 2025K251676Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microte
Microtek Medical, LLC
LHI
Jul 18, 2025K243404HyHub™ and HyHub™ Duo Vial Access Devices
Takeda Pharmaceuticals
LHI
Mar 21, 2025K240761Arisure® Closed Male Luer with Spike Adapter (YM060)
Yukon Medical, LLC
LHI
Jan 22, 2025K243985Rio™ Drug Reconstitution Transfer Device
Icu Medical, Inc.
LHI
Dec 6, 2024K243486SmartSiteTM Vented Vial Access Device
Yukon Medical, LLC
LHI
Sep 6, 2024K241976nextaro® va, 15mm, 5µm
Sfm Medical Devices GmbH, DE
LHI
Jul 26, 2024K233287Vent Vial Adapter
Hangzhou Qiantang Longyue Biotechnology Co., Ltd., CN
LHI
Jun 26, 2024K232987FlowArt Valve for Vial Access
Asset Medikal Tasarim Sanayi VE Ticaret A.S., TR
LHI
May 3, 2024K240940Vial2Bag Advanced® 20mm Admixture Device
West Pharmaceutical Services, Inc.
LHI
May 1, 2024K233284Vial Adapter with Filter
Hangzhou Qiantang Longyue Biotechnology Co., Ltd., CN
LHI
Apr 16, 2024K240748nextaro® v, 20/20
Sfm Medical Devices GmbH, DE
LHI
Mar 6, 2024K233021BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device
Care Fusion
LHI
Jan 19, 2024K231071Mix2Vial® Transfer Device
West Pharma. Services IL, Ltd., IL
LHI
Dec 14, 2023K232875Vial Adapter 20mm
West Pharma. Services IL, Ltd., IL
LHI
Dec 1, 2023K230988Vial2Bag Advanced® 13mm Admixture Device
West Pharma. Services IL, Ltd., IL
LHI
Oct 6, 2023K232055Vial Adapter
Shanghai Lingfu Technology Co., Ltd., CN
LHI
May 22, 2023K230464MixJect® Transfer Device
West Pharma. Services IL, Ltd., IL
LHI
Mar 10, 2023K222718Vial Adapter
Hangzhou Qiantang Longyue Biotechnology Co., Ltd., CN
LHI
Aug 31, 2022K213513Vented Vial Adapter 20mm
West Pharma. Services IL, Ltd., IL
LHI
Aug 19, 2022K212525Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices
Advcare Medical, TW
LHI
Jun 21, 2022K220856Vial Adapter Ø13mm
Avenir Performance Européenne Medical (Apem), FR
LHI
Jun 1, 2022K212445freeflex+ Transfer Adapter
Fresenius Kabi AG, DE
LHI
Apr 24, 2022K212530IVX Fluid Transfer Set
Omnicell, Inc.
LHI
Nov 3, 2021K202732SOL-CARE IV Bag Safety Connector
Sol-Millennium Medical Group
LHI
Sep 27, 2021K203674B Dispensing Line
Aea Srl, IT
LHI
May 4, 2021K200893ProntoPump Sterile Tube Set
Ipax, Inc.
LHI
Dec 9, 2020K201469Mini Spike Plus 6/8R
B.Braun Medical, Inc.
LHI
Oct 21, 2020K201415Vial2Bag Advanced 20mm Admixture Device
West Pharmaceutical Services Az, Inc.
LHI
Apr 20, 2020K192154Rio Vial-to-Bag Drug Reconstitution Device
Icu Medical
LHI
Dec 2, 2019K182819Decanting Device
Gcmedica Enterprise Ltd.(Wuxi), CN
LHI
Nov 19, 2019K190816Vial Adapter Ø20 mm , Vial Adapter Ø13 mm
Avenir Performance Europeenne Medical (Apem), FR
LHI
Oct 15, 2019K190149Vial Adapter Ø20 mm
Avenir Performance Europeenne Medical (Apem), FR
LHI
Mar 15, 2019K183187nextaro Transfer System, nextaro va
Sfm Medical Devices GmbH, DE
LHI
Jun 7, 2018K173577Guarded Luer Connector
International Medical Industries, Inc.
LHI
Oct 19, 2017K162216GRI-FILL PERISTALTIC SET
Laboratorios Grifols, S.A., ES
LHI
Oct 12, 2017K171796Vial Adapter 15mm
Medimop Medical Project , Ltd., IL
LHI
Oct 3, 2017K172884Arisure Closed Vial Adapter
Yukon Medical
LHI
Sep 29, 2017K172631Arisure Dry Spike
Yukon Medical
LHI
Mar 8, 2017K170095Vial2Bag Direct Connect
Medimop Medical Project , Ltd., IL
LHI
Dec 6, 2016K161800OnSite-IV
Pharmc, LLC
LHI
May 4, 2016K160503Vented Vial Adapter Transfer Device - 13mm
Medimop Medical Projects, Ltd., IL
LHI
Feb 19, 2016K151423APEX Compounding System Transfer Set
B.Braun Medical, Inc.
LHI
Dec 4, 2015K152441KIRO Set
Kiro Robotics S.L., ES
LHI
Dec 2, 2015K150787Universal Spike
B.Braun Medical, Inc.
LHI
Jul 31, 2015K151963SmartSite Vented Vial Access Device
Yukon Medical, LLC
LHI
Nov 19, 2014K142600VIAL-MATE Adaptor
Baxter Healthcare Corporation
LHI

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