Cleared Traditional

K053607 - BREAS VIVO 40 SYSTEM

K053607 is an FDA 510(k) clearance for BREAS VIVO 40 SYSTEM, manufactured by Breas Medical AB. The device is a Class 2 Anesthesiology device with product code MNT cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K053607 · Breas Medical AB · Anesthesiology device
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Mar 2006
Decision
79d
Days
Class 2
Risk

K053607 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, Vastra Gotaland, SE). The FDA issued a Cleared decision on March 16, 2006 after a review of 79 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 Breas Medical AB devices

FDA 510(k) Submission Details - K053607

510(k) Number K053607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2005
Decision Date March 16, 2006
Days to Decision 79 days
Submission Type Traditional
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
61d faster than avg
Panel avg: 140d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNT Device Classification - Class 2, Special Controls

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 24
Devices cleared under the same product code (MNT) and FDA review panel - the closest regulatory comparables to K053607.
V60 VENTILATOR, MODEL V8000
K082660 · Respironics California, Inc. · Jan 2009
BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 40
K071702 · Breas Medical AB · Feb 2008
ACUTE CARE FACE MASK, MODEL RT040
K060044 · Fisher &Paykel Healthcare , Ltd. · Apr 2006
KNIGHTSTAR 330 VENTILATOR
K003075 · Mallinckrodt, Inc. · Dec 2001
STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964
K990574 · Respironics, Inc. · May 1999
BIPAP VISION VENTILATORY SUPPORT
K982454 · Respironics, Inc. · Nov 1998