Cleared Traditional

K103345 - BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S) (FDA 510(k) Clearance)

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

K103345 · Breathe Technologies, Inc. · Anesthesiology device
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Feb 2011
Decision
88d
Days
Class 2
Risk

K103345 is an FDA 510(k) clearance for the BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S). Classified as Mechanical Ventilator (product code ONZ), Class II - Special Controls.

Submitted by Breathe Technologies, Inc. (San Ramon, US). The FDA issued a Cleared decision on February 11, 2011 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Breathe Technologies, Inc. devices

Submission Details

510(k) Number K103345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2010
Decision Date February 11, 2011
Days to Decision 88 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
51d faster than avg
Panel avg: 139d · This submission: 88d
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.