Cleared Traditional

K092031 - VAPOR-CLEAR

K092031 is an FDA 510(k) clearance for VAPOR-CLEAR, manufactured by Axon Medical, Inc.. The device is a Class 2 Anesthesiology device with product code CBN cleared through the Traditional 510(k) pathway after a 284-day FDA review.

K092031 · Axon Medical, Inc. · Anesthesiology device
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Apr 2010
Decision
284d
Days
Class 2
Risk

K092031 is an FDA 510(k) clearance for the VAPOR-CLEAR, MODEL 100. Classified as Apparatus, Gas-scavenging (product code CBN), Class II - Special Controls.

Submitted by Axon Medical, Inc. (Park City, US). The FDA issued a Cleared decision on April 16, 2010 after a review of 284 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5430 - 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 Axon Medical, Inc. devices

FDA 510(k) Submission Details - K092031

510(k) Number K092031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2009
Decision Date April 16, 2010
Days to Decision 284 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
144d slower than avg
Panel avg: 140d · This submission: 284d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBN Device Classification - Class 2, Special Controls

Product Code CBN Apparatus, Gas-scavenging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5430
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 - CBN Apparatus, Gas-scavenging

All 14
Devices cleared under the same product code (CBN) and FDA review panel - the closest regulatory comparables to K092031.
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