Cleared Special

K100772 - MIRAGE MICRO MODEL 16333 (S), 16334 (M&L), 16335 (LW & XL) (FDA 510(k) Clearance)

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

K100772 · Resmed, Ltd. · Anesthesiology device
Jun 2010
Decision
83d
Days
Class 2
Risk

K100772 is an FDA 510(k) clearance for the MIRAGE MICRO MODEL 16333 (S), 16334 (M&L), 16335 (LW & XL). Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Resmed, Ltd. (San Diego, US). The FDA issued a Cleared decision on June 9, 2010 after a review of 83 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 K100772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2010
Decision Date June 09, 2010
Days to Decision 83 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Statement
Regulatory Context
Review time vs. panel average
142d faster than avg
Panel avg: 225d · This submission: 83d
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
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