Cleared Traditional

K231380 - AirLife DuoTherm Humidification System

K231380 is an FDA 510(k) clearance for AirLife DuoTherm Humidification System, manufactured by Vyaire Medical, Inc.. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K231380 · Vyaire Medical, Inc. · Anesthesiology device
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Aug 2023
Decision
90d
Days
Class 2
Risk

K231380 is an FDA 510(k) clearance for the AirLife DuoTherm™ Humidification System. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Vyaire Medical, Inc. (Mettawa, US). The FDA issued a Cleared decision on August 10, 2023 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5450 - 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 Vyaire Medical, Inc. devices

FDA 510(k) Submission Details - K231380

510(k) Number K231380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2023
Decision Date August 10, 2023
Days to Decision 90 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
50d faster than avg
Panel avg: 140d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTT Device Classification - Class 2, Special Controls

Product Code BTT Humidifier, Respiratory Gas, (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5450
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 - BTT Humidifier, Respiratory Gas, (direct Patient Interface)

All 108
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K231380.
Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260)
K230559 · Medline Industries, Inc. · Oct 2023
BONHAWA Respiratory Humidifier
K223863 · Telesair, Inc. · Oct 2023
F&P 820 Humidification System
K223684 · Fisher &Paykel Healthcare , Ltd. · Sep 2023
Sterile Water for Inhalation in 1L Flexoval ® bottles.
K223551 · Hometa, Inc. · Aug 2023
F&P 950 Respiratory Humidifier
K220703 · Fisher & Paykel Healthcare · Jun 2023
F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range
K222197 · Fisher &Paykel Healthcare , Ltd. · Apr 2023