Cleared Traditional

K072588 - PERFORMAX SE TOTAL FACE MASK

K072588 is an FDA 510(k) clearance for 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 Traditional 510(k) pathway after a 95-day FDA review.

K072588 · Respironics Inc., Sleep & Home Respiratory Group · Anesthesiology device
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Dec 2007
Decision
95d
Days
Class 2
Risk

K072588 is an FDA 510(k) clearance for the 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, 2007 after a review of 95 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

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

FDA 510(k) Submission Details - K072588

510(k) Number K072588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2007
Decision Date December 18, 2007
Days to Decision 95 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
45d faster than avg
Panel avg: 140d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 320
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K072588.
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MODIFICATION TO GALILEO GOLD
K080181 · Hamilton Medical AG · Jun 2008
SERVO-I VENTILATOR SYSTEM MODEL 64 87 800 E4073, HELIOX OPTION, MODEL 6675585
K073179 · Maquet Critical Care AB · Jun 2008
HAMILTON-G5
K070513 · Hamilton Medical AG · Nov 2007
RAPHAEL COLOR ASV VENTILATOR
K071194 · Hamilton Medical AG · Oct 2007
SLEEPNET MOJO -NV FULL FACE MASK, NON-VENTED
K063806 · Sleepnet Corporation · May 2007