Cleared Special

K100528 - BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S

K100528 is an FDA 510(k) clearance for BREATHE TECHNOLOGIES VENTILATOR AND ACC..., manufactured by Breathe Technologies, Inc.. The device is a Class 2 Anesthesiology device with product code ONZ cleared through the Special 510(k) pathway after a 58-day FDA review.

K100528 · Breathe Technologies, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
58d
Days
Class 2
Risk

K100528 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 April 23, 2010 after a review of 58 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K100528

510(k) Number K100528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2010
Decision Date April 23, 2010
Days to Decision 58 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 140d · This submission: 58d
Pathway characteristics
Modification to existing cleared device.

ONZ Device Classification - Class 2, Special Controls

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.

Regulatory Peers - ONZ Mechanical Ventilator

Devices cleared under the same product code (ONZ) and FDA review panel - the closest regulatory comparables to K100528.
BREATHE NIOV VENTILATION SYSTEM
K131562 · Breathe Technologies · Mar 2014
BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)
K103345 · Breathe Technologies, Inc. · Feb 2011
BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)
K102525 · Breathe Technologies, Inc. · Dec 2010
BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES
K082982 · Breathe Technologies, Inc. · Jul 2009