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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 a medical device manufactured by Icu Medical, Inc.. It received FDA 510(k) clearance on 2025-01-22 under approval 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. It is manufactured by Icu Medical, Inc.. The 510(k) number is K243985.

When was Rio™ Drug Reconstitution Transfer Device approved by the FDA?

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

What company makes Rio™ Drug Reconstitution Transfer Device?

Rio™ Drug Reconstitution Transfer Device is manufactured by Icu Medical, Inc..

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

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

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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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