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510(k) K192154

Device
Rio Vial-to-Bag Drug Reconstitution Device
Applicant
ICU Medical
510(k) number
K192154
Product code
LHI  
Decision
Substantially Equivalent (SESE)
Decision date
2020-04-20
Date received
2019-08-09
Regulation
880.5440
Classification name
Set, I.v. Fluid Transfer
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Sheila Antonio
Address
951 Calle Amanecer San Clemente CA US 92673 92673

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LHI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252987ADRx™ Admixture DeviceEpic Medical Pte. , Ltd.2026-06-12
K260301Vial AdapterHangzhou Qiantang Longyue Biotechnology Co., Ltd.2026-06-05
K250345Medline Bag DecanterMedline Industries, LP2025-10-24
K251715FlowArt® Vial Access Device VentedAsset Medikal2025-10-14
K251676Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)Microtek Medical, LLC2025-09-16
K243404HyHub™ and HyHub™ Duo Vial Access DevicesTakeda Pharmaceuticals2025-07-18
K240761Arisure® Closed Male Luer with Spike Adapter (YM060)Yukon Medical, LLC2025-03-21
K243985Rio™ Drug Reconstitution Transfer DeviceIcu Medical, Inc.2025-01-22
K243486SmartSiteTM Vented Vial Access DeviceYukon Medical, LLC2024-12-06
K241976nextaro® va, 15mm, 5µmSfm Medical Devices GmbH2024-09-06
K233287Vent Vial AdapterHangzhou Qiantang Longyue Biotechnology Co., Ltd.2024-07-26
K232987FlowArt Valve for Vial AccessAsset Medikal Tasarim Sanayi VE Ticaret A.S.2024-06-26
K240940Vial2Bag Advanced® 20mm Admixture DeviceWest Pharmaceutical Services, Inc.2024-05-03
K233284Vial Adapter with FilterHangzhou Qiantang Longyue Biotechnology Co., Ltd.2024-05-01
K240748nextaro® v, 20/20Sfm Medical Devices GmbH2024-04-16

Legacy Summary#

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FDA Review#

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