Cleared Traditional

SONARMED AIRWAY MONITORING SYSTEM, MODEL 0901 (K092611) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K092611 · Sonarmed, Inc. · Anesthesiology device
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Apr 2010
Decision
245d
Days
Class 2
Risk

K092611 is an FDA 510(k) clearance for the SONARMED AIRWAY MONITORING SYSTEM, MODEL 0901. Classified as Airway Monitoring System (product code OQU), Class II - Special Controls.

Submitted by Sonarmed, Inc. (Indianapolis, US). The FDA issued a Cleared decision on April 28, 2010 after a review of 245 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5730 - 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 Sonarmed, Inc. devices

Submission Details

510(k) Number K092611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2009
Decision Date April 28, 2010
Days to Decision 245 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
106d slower than avg
Panel avg: 139d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OQU Airway Monitoring System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5730
Definition The Device Is Intended To Assist In Verifying Ett Tube Placement, Assist In Detecting Ett Tube Movement And Obstruction Of The Tube Tip
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.