Cleared Special

K092648 - RESPIRONICS PERFORMAX SE TOTAL FACE MASK (FDA 510(k) Clearance)

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

K092648 · Respironics Inc., Sleep & Home Respiratory Group · Anesthesiology device
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Dec 2009
Decision
112d
Days
Class 2
Risk

K092648 is an FDA 510(k) clearance for the RESPIRONICS PERFORMAX SE TOTAL FACE MASK. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Respironics Inc., Sleep & Home Respiratory Group (Murrysville, US). The FDA issued a Cleared decision on December 18, 2009 after a review of 112 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Respironics Inc., Sleep & Home Respiratory Group devices

Submission Details

510(k) Number K092648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2009
Decision Date December 18, 2009
Days to Decision 112 days
Submission Type Special
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: 139d · This submission: 112d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code CBK Ventilator, Continuous, 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 - CBK Ventilator, Continuous, Facility Use

All 503
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