Cleared Traditional

K050359 - ULTRA MIRAGE II MASK

K050359 is an FDA 510(k) clearance for ULTRA MIRAGE II MASK, manufactured by Resmed, Ltd.. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K050359 · Resmed, Ltd. · Anesthesiology device
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Mar 2005
Decision
30d
Days
Class 2
Risk

K050359 is an FDA 510(k) clearance for the ULTRA MIRAGE II MASK. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Resmed, Ltd. (Poway, US). The FDA issued a Cleared decision on March 16, 2005 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - 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 Resmed, Ltd. devices

FDA 510(k) Submission Details - K050359

510(k) Number K050359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2005
Decision Date March 16, 2005
Days to Decision 30 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
110d faster than avg
Panel avg: 140d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZD Device Classification - Class 2, Special Controls

Product Code BZD Ventilator, Non-continuous (respirator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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 - BZD Ventilator, Non-continuous (respirator)

All 391
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K050359.
PIONEER U121 SERIES CPAP
K041823 · Merits Health Products Co., Ltd. · May 2005
RESSCAN
K050775 · Resmed, Ltd. · May 2005
IT NASAL MASK
K050171 · Innomed Technologies · May 2005
AURA CPAP SYSTEM
K042945 · Aeiomed, Inc. · Mar 2005
SALTER LABS CPAP HIGH FLOW CANNULA SYSTEM
K040202 · Salter Labs · Mar 2005
RESMED MERIDIAN MASK
K050142 · Resmed, Ltd. · Mar 2005