Cleared Special

K030798 - MIRAGE ACTIVA MASK (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K030798 · Resmed, Ltd. · Anesthesiology device
Apr 2003
Decision
27d
Days
Class 2
Risk

K030798 is an FDA 510(k) clearance for the MIRAGE ACTIVA 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 April 9, 2003 after a review of 27 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. 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.

Submission Details

510(k) Number K030798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2003
Decision Date April 09, 2003
Days to Decision 27 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
198d faster than avg
Panel avg: 225d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 19
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K030798.
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