Cleared Traditional

BREAS VIVO 40 SYSTEM (K090113) - FDA 510(k) Clearance

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

K090113 · Breas Medical AB · Anesthesiology device
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May 2009
Decision
113d
Days
Class 2
Risk

K090113 is an FDA 510(k) clearance for the BREAS VIVO 40 SYSTEM. Classified as Ventilator, Continuous, Minimal Ventilatory Support, Facility Use (product code MNT), Class II - Special Controls.

Submitted by Breas Medical AB (Molnlycke, SE). The FDA issued a Cleared decision on May 14, 2009 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 868.5895 - 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 Breas Medical AB devices

Submission Details

510(k) Number K090113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2009
Decision Date May 14, 2009
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
27d faster than avg
Panel avg: 140d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MNT Ventilator, Continuous, Minimal Ventilatory Support, 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 - MNT Ventilator, Continuous, Minimal Ventilatory Support, Facility Use

All 13
Devices cleared under the same product code (MNT) and FDA review panel - the closest regulatory comparables to K090113.
F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version
K191624 · Fisher & Paykel Healthcare Limited · Mar 2020
BIPAP A 40 VENTILATORY SUPPORT SYSTEM
K121623 · Respironics, Inc. · Dec 2012
V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS
K102985 · Respironics, Inc. · Apr 2011
STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964
K990574 · Respironics, Inc. · May 1999
BIPAP VISION VENTILATORY SUPPORT
K982454 · Respironics, Inc. · Nov 1998
BIPAP S/T-D 30 SYSTEM
K955324 · Respironics, Inc. · Dec 1996