Cleared Traditional

PNEUTON MINI VENTILATOR PNEUTON MINI NON-INVASIVE VENTILATION (NIV) KIT ACCESSORY (K121379) - FDA 510(k) Clearance

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

K121379 · Airon Corporation · Anesthesiology device
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Oct 2012
Decision
156d
Days
Class 2
Risk

K121379 is an FDA 510(k) clearance for the PNEUTON MINI VENTILATOR PNEUTON MINI NON-INVASIVE VENTILATION (NIV) KIT ACCES.... Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Airon Corporation (Melbourne, US). The FDA issued a Cleared decision on October 11, 2012 after a review of 156 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 Airon Corporation devices

Submission Details

510(k) Number K121379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2012
Decision Date October 11, 2012
Days to Decision 156 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
16d slower than avg
Panel avg: 140d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CBK Ventilator, Continuous, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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 - CBK Ventilator, Continuous, Facility Use

All 112
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K121379.
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PERFORMAX PEDIATRIC SE TOTAL FACE MASK
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K111610 · Respironics, Inc. · Oct 2011
ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASK
K101129 · Respironics, Inc. · Sep 2010