Cleared Special

K092648 - RESPIRONICS PERFORMAX SE TOTAL FACE MASK

K092648 is an FDA 510(k) clearance for RESPIRONICS PERFORMAX SE TOTAL FACE MASK, manufactured by Respironics Inc., Sleep & Home Respiratory Group. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Special 510(k) pathway after a 112-day FDA review.

K092648 · Respironics Inc., Sleep & Home Respiratory Group · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K092648

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 140d · This submission: 112d
Pathway characteristics
Modification to existing cleared device.

CBK Device Classification - Class 2, Special Controls

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 435
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K092648.
HAMILTON-C2
K092148 · Hamilton Medical AG · Mar 2010
TRILOGY 200 VENTILATOR
K093416 · Respironics, Inc. · Jan 2010
ENDURAVENT-5 VENTILATOR
K092263 · Providence Global Medical, Inc. · Jan 2010
ATLANTIS HYPERBARIC CHAMBER VENTILATOR
K092264 · Providence Global Medical, Inc. · Dec 2009
MODIFICATION TO IVENT 101
K092135 · Versamed Medical Systems , Ltd. · Nov 2009
NEWPORT HT70 FAMILY OF VENTILATORS
K090888 · Newport Medical Instruments, Inc. · Nov 2009