Cleared Traditional

AirLife DuoTherm? Humidification System

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

About This 510(k) Submission

K231380 is an FDA 510(k) clearance for the AirLife DuoTherm? Humidification System, a Humidifier, Respiratory Gas, (direct Patient Interface) (Class II — Special Controls, product code BTT), submitted by Vyaire Medical, Inc. (Mettawa, US). The FDA issued a Cleared decision on August 10, 2023, 90 days after receiving the submission on May 12, 2023. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5450.

Submission Details

510(k) Number K231380 FDA.gov
FDA Decision Cleared 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

Device Classification

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

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