Cleared Traditional

K120216 - GENOSYL MV-1000 (FDA 510(k) Clearance)

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

K120216 · Geno, LLC · Anesthesiology device
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May 2012
Decision
113d
Days
Class 2
Risk

K120216 is an FDA 510(k) clearance for the GENOSYL MV-1000. Classified as Apparatus, Nitric Oxide Delivery (product code MRN), Class II - Special Controls.

Submitted by Geno, LLC (Cocoa, US). The FDA issued a Cleared decision on May 16, 2012 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5165 - 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.

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Submission Details

510(k) Number K120216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2012
Decision Date May 16, 2012
Days to Decision 113 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
26d faster than avg
Panel avg: 139d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MRN Apparatus, Nitric Oxide Delivery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5165
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.

Regulatory Peers - MRN Apparatus, Nitric Oxide Delivery

All 32
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