Cleared Traditional

K131562 - BREATHE NIOV VENTILATION SYSTEM (FDA 510(k) Clearance)

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

K131562 · Breathe Technologies · Anesthesiology device
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Mar 2014
Decision
280d
Days
Class 2
Risk

K131562 is an FDA 510(k) clearance for the BREATHE NIOV VENTILATION SYSTEM. Classified as Mechanical Ventilator (product code ONZ), Class II - Special Controls.

Submitted by Breathe Technologies (Alameda, US). The FDA issued a Cleared decision on March 6, 2014 after a review of 280 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.

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Submission Details

510(k) Number K131562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2013
Decision Date March 06, 2014
Days to Decision 280 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
141d slower than avg
Panel avg: 139d · This submission: 280d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ONZ Mechanical Ventilator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
Definition This Device Is A Volume Assist Ventilator Intended To Aid Adult Patients With Respiratory Insufficiency. It Is Designed For Patients Who Are Capable Of Spontaneously Breathing A Minimum Tidal Volume Of 3.5cc/kg Of Predicted Body Weight. The Device Is Designed For Continuous Applications Such As Patient Ambulation, Physical Therapy, Occupational Therapy, Respiratory Therapy, And Other Rehabilitation Efforts In An Institutional Or Home Care Environment. The Device Is Intended For Operation By Trained Personnel, Patients Or Caregiver Under The Direction Of A Physician,
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.