Cleared Traditional

Rio? Drug Reconstitution Transfer Device

K243985 · Icu Medical, Inc. · General Hospital
Jan 2025
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K243985 is an FDA 510(k) clearance for the Rio? Drug Reconstitution Transfer Device, a Set, I.v. Fluid Transfer (Class II — Special Controls, product code LHI), submitted by Icu Medical, Inc. (San Clemente, US). The FDA issued a Cleared decision on January 22, 2025, 30 days after receiving the submission on December 23, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K243985 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 2024
Decision Date January 22, 2025
Days to Decision 30 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LHI — Set, I.v. Fluid Transfer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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