Cleared Traditional

AirFit F20 Mask System; AirFit F20 NM Mask System

K242547 · Resmed Pty , Ltd. · Anesthesiology

May 2025

Decision

265d

Days

Class 2

Risk

About This 510(k) Submission

K242547 is an FDA 510(k) clearance for the AirFit F20 Mask System; AirFit F20 NM Mask System, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Resmed Pty , Ltd. (Bella Vista, AU). The FDA issued a Cleared decision on May 19, 2025, 265 days after receiving the submission on August 27, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number	K242547 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 27, 2024
Decision Date	May 19, 2025
Days to Decision	265 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF