Cleared Abbreviated

IMAGE3 SE DISPOSABLE FULL FACE MASK (K023135) - FDA 510(k) Clearance

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

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

Submission Details

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.

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 73
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K023135.
TRILOGY 202 VENTILATOR
K093905 · Respironics, Inc. · May 2010
TRILOGY 200 VENTILATOR
K093416 · Respironics, Inc. · Jan 2010
ESPRIT VENTILATOR, MODEL V1000
K034040 · Respironics, Inc. · Jan 2004
SERVO VENTILATOR SYSTEM, MODEL 64 87 800 E407E
K022132 · Siemens Medical Solutions USA, Inc. · Sep 2002
ESPIRT
K001208 · Respironics, Inc. · May 2000
ESPRIT VENTILATOR
K981072 · Respironics, Inc. · Nov 1998