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FDA 510(k)

Rio™ Drug Reconstitution Transfer Device

K-Number: K243985 · 2025-01-22

ApplicantIcu Medical, Inc.
Decision Date2025-01-22
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Rio™ Drug Reconstitution Transfer Device is the device name listed in this FDA 510(k) record. The listed applicant is Icu Medical, Inc.. It received FDA 510(k) clearance on 2025-01-22 under 510(k) number K243985. 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™ Drug Reconstitution Transfer Device?

Rio™ Drug Reconstitution Transfer Device is a medical device that received FDA 510(k) clearance on 2025-01-22. The listed applicant is Icu Medical, Inc.. The 510(k) number is K243985.

When did Rio™ Drug Reconstitution Transfer Device receive FDA 510(k) clearance?

Rio™ Drug Reconstitution Transfer Device received FDA 510(k) clearance on 2025-01-22, under 510(k) number K243985.

Who is the listed applicant for Rio™ Drug Reconstitution Transfer Device?

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

What is the FDA product code for Rio™ Drug Reconstitution Transfer Device?

The FDA product code for Rio™ Drug Reconstitution Transfer Device is LHI.

Other records listing Icu Medical, Inc. as applicant

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Related Devices (Code: LHI)

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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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