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FDA 510(k)

Rio Vial-to-Bag Drug Reconstitution Device

K-Number: K192154 · 2020-04-20

ApplicantIcu Medical
Decision Date2020-04-20
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Rio Vial-to-Bag Drug Reconstitution Device is the device name listed in this FDA 510(k) record. The listed applicant is Icu Medical. It received FDA 510(k) clearance on 2020-04-20 under 510(k) number K192154. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rio Vial-to-Bag Drug Reconstitution Device?

Rio Vial-to-Bag Drug Reconstitution Device is a medical device that received FDA 510(k) clearance on 2020-04-20. The listed applicant is Icu Medical. The 510(k) number is K192154.

When did Rio Vial-to-Bag Drug Reconstitution Device receive FDA 510(k) clearance?

Rio Vial-to-Bag Drug Reconstitution Device received FDA 510(k) clearance on 2020-04-20, under 510(k) number K192154.

Who is the listed applicant for Rio Vial-to-Bag Drug Reconstitution Device?

The FDA 510(k) record lists Icu Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rio Vial-to-Bag Drug Reconstitution Device?

The FDA product code for Rio Vial-to-Bag Drug Reconstitution Device is LHI.

Other records listing Icu Medical as applicant

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Related Devices (Code: LHI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252987ADRx™ Admixture DeviceEpic Medical Pte. , Ltd.K260301Vial AdapterHangzhou Qiantang Longyue Biotechnology Co., Ltd.K250345Medline Bag DecanterMedline Industries, LPK251715FlowArt® Vial Access Device VentedAsset MedikalK251676Medline 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, LLCK243404HyHub™ and HyHub™ Duo Vial Access DevicesTakeda Pharmaceuticals

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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