Cleared Traditional

AirFit F20 Mask System (K242547) - FDA 510(k) Clearance

Also marketed or referenced as:
AirFit F20 NM Mask System

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

K242547 · Resmed Pty , Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
265d
Days
Class 2
Risk

K242547 is an FDA 510(k) clearance for the AirFit F20 Mask System. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Resmed Pty , Ltd. (Bella Vista, AU). The FDA issued a Cleared decision on May 19, 2025 after a review of 265 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - 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 Resmed Pty , Ltd. devices

Submission Details

510(k) Number K242547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
125d slower than avg
Panel avg: 140d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZD Ventilator, Non-continuous (respirator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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 Consultant

Resmed Corp
Jason Gorman

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - BZD Ventilator, Non-continuous (respirator)

All 130
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K242547.
F&P Nova Nasal Mask
K243583 · Fisher & Paykel Healthcare Limited · Jun 2025
myAir
K250624 · ResMed Corp · May 2025
WiZARD 520 Full Face Mask
K243023 · Wellell, Inc. · May 2025
Respiration Data Management Software (PAP Link PC)
K242935 · BMC Medical Co., Ltd. · Jan 2025
Nasal Pillow Mask - Small (NNPM-01/ Nefes S)
K243225 · Genadyne Biotechnologies, Inc. · Dec 2024
Mojo Full Face Vented Mask
K241830 · Sleepnet Corporation · Oct 2024