Cleared Traditional

K123144 - VIVO 50 (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K123144 · Ge Healthcare, Breas Medical AB · Anesthesiology device
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Jun 2013
Decision
256d
Days
Class 2
Risk

K123144 is an FDA 510(k) clearance for the VIVO 50. Classified as Continuous, Ventilator, Home Use (product code NOU), Class II - Special Controls.

Submitted by Ge Healthcare, Breas Medical AB (Molnlycke, SE). The FDA issued a Cleared decision on June 18, 2013 after a review of 256 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ge Healthcare, Breas Medical AB devices

Submission Details

510(k) Number K123144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2012
Decision Date June 18, 2013
Days to Decision 256 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 139d · This submission: 256d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NOU Continuous, Ventilator, Home Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
Definition This Product Code Was Needed For The Home Use Indication. Cbk Is Not A Tracked Device And Nou Is A Tracked Device.
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 Anesthesiology devices follow this clearance model.