Cleared Traditional

SonarMed AirWave, Airway Monitoring System (K143042) - FDA 510(k) Clearance

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

K143042 · Sonarmed, Inc. · Anesthesiology device
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Jan 2016
Decision
457d
Days
Class 2
Risk

K143042 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 January 22, 2016 after a review of 457 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Sonarmed, Inc. devices

Submission Details

510(k) Number K143042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2014
Decision Date January 22, 2016
Days to Decision 457 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
318d slower than avg
Panel avg: 139d · This submission: 457d
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.