Cleared Traditional

SonarMed AirWave Airway Monitoring System (K193058) - FDA 510(k) Clearance

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

K193058 · Sonarmed, Inc. · Anesthesiology device
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May 2020
Decision
196d
Days
Class 2
Risk

K193058 is an FDA 510(k) clearance for the SonarMed AirWave Airway Monitoring System. Classified as Airway Monitoring System (product code OQU), Class II - Special Controls.

Submitted by Sonarmed, Inc. (Carmel, US). The FDA issued a Cleared decision on May 15, 2020 after a review of 196 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 K193058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2019
Decision Date May 15, 2020
Days to Decision 196 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
57d slower than avg
Panel avg: 139d · This submission: 196d
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.