Cleared Abbreviated

K023135 - IMAGE3 SE DISPOSABLE FULL FACE MASK

K023135 is an FDA 510(k) clearance for IMAGE3 SE DISPOSABLE FULL FACE MASK, manufactured by Respironics, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Abbreviated 510(k) pathway after a 105-day FDA review.

K023135 · Respironics, Inc. · Anesthesiology device
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Jan 2003
Decision
105d
Days
Class 2
Risk

K023135 is an FDA 510(k) clearance for the IMAGE3 SE DISPOSABLE FULL FACE MASK. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on January 3, 2003 after a review of 105 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Respironics, Inc. devices

FDA 510(k) Submission Details - K023135

510(k) Number K023135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2002
Decision Date January 03, 2003
Days to Decision 105 days
Submission Type Abbreviated
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
35d faster than avg
Panel avg: 140d · This submission: 105d
Pathway characteristics
Standards-based clearance path.

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 249
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K023135.
ESPRIT VENTILATOR, MODEL V1000
K034040 · Respironics, Inc. · Jan 2004
RAPHAEL
K022679 · Hamilton Medical AG · Oct 2003
DATEX-OHMEDA 7900 VENTILATOR ENHANCEMENTS
K023366 · Datex-Ohmeda, Inc. · Oct 2003
BIRD AVEA VENTILATOR
K022674 · Bird Products Corp. · Nov 2002
SERVO VENTILATOR SYSTEM, MODEL 64 87 800 E407E
K022132 · Siemens Medical Solutions USA, Inc. · Sep 2002
AVEA
K013642 · Bird Products Corp. · May 2002