Cleared Traditional

K160481 - Vivo 60

K160481 is an FDA 510(k) clearance for Vivo 60, manufactured by Breas Medical AB. The device is a Class 2 Anesthesiology device with product code NOU cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K160481 · Breas Medical AB · Anesthesiology device
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Nov 2016
Decision
261d
Days
Class 2
Risk

K160481 is an FDA 510(k) clearance for the Vivo 60. Classified as Continuous, Ventilator, Home Use (product code NOU), Class II - Special Controls.

Submitted by Breas Medical AB (Molnlycke Vastra Gotalands Lan, SE). The FDA issued a Cleared decision on November 9, 2016 after a review of 261 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 Breas Medical AB devices

FDA 510(k) Submission Details - K160481

510(k) Number K160481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2016
Decision Date November 09, 2016
Days to Decision 261 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
121d slower than avg
Panel avg: 140d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NOU Device Classification - Class 2, Special Controls

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.