Cleared Traditional

K192154 - Rio Vial-to-Bag Drug Reconstitution Device

K192154 is an FDA 510(k) clearance for Rio Vial-to-Bag Drug Reconstitution Device, manufactured by Icu Medical. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 255-day FDA review.

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

K192154 is an FDA 510(k) clearance for the Rio Vial-to-Bag Drug Reconstitution Device. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Icu Medical (San Clemente, US). The FDA issued a Cleared decision on April 20, 2020 after a review of 255 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Icu Medical devices

FDA 510(k) Submission Details - K192154

510(k) Number K192154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 129d · This submission: 255d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LHI Device Classification - Class 2, Special Controls

Product Code LHI Set, I.v. Fluid Transfer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - LHI Set, I.v. Fluid Transfer

All 73
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K192154.
ProntoPump Sterile Tube Set
K200893 · Ipax, Inc. · May 2021
Mini Spike Plus 6/8R
K201469 · B.Braun Medical, Inc. · Dec 2020
Vial2Bag Advanced 20mm Admixture Device
K201415 · West Pharmaceutical Services Az, Inc. · Oct 2020
Decanting Device
K182819 · Gcmedica Enterprise Ltd.(Wuxi) · Dec 2019
Vial Adapter Ø20 mm , Vial Adapter Ø13 mm
K190816 · Avenir Performance Europeenne Medical (Apem) · Nov 2019
Vial Adapter Ø20 mm
K190149 · Avenir Performance Europeenne Medical (Apem) · Oct 2019