Cleared Traditional

Rio Vial-to-Bag Drug Reconstitution Device

K192154 · Icu Medical · General Hospital
Apr 2020
Decision
255d
Days
Class 2
Risk

About This 510(k) Submission

K192154 is an FDA 510(k) clearance for the Rio Vial-to-Bag Drug Reconstitution Device, a Set, I.v. Fluid Transfer (Class II — Special Controls, product code LHI), submitted by Icu Medical (San Clemente, US). The FDA issued a Cleared decision on April 20, 2020, 255 days after receiving the submission on August 9, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K192154 FDA.gov
FDA Decision Cleared SESE
Date Received August 09, 2019
Decision Date April 20, 2020
Days to Decision 255 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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