# K242547: AirFit F20 Mask System; AirFit F20 NM Mask System

- Pathway: 510(k) (Traditional)
- Applicant: Resmed Pty, Ltd.
- Decided: May 19, 2025 after 265 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K982530 (1998). 26 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170924: AirFit F20, Resmed, Ltd. (2018) Summary page 5.

## Most influential descendants
- K261262: Altis Full Face Mask (2026), 0 descendants of its own

## Indications for use
AirFit F20 Mask System: The AirFit F20 mask has two product variants: • AirFit F20 mask is intended for single-patent reuse in the home environment. • AirFit F20 SLM (Sleep Lab Mask) variant is intended for multi-patient reuse in the hospital/institutional environment. Both masks are intended for patients weighing more than 66lb (30kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. The Sleep Lab Mask is the only variant that is validated and intended for multi-patient reprocessing and must be reprocesssed if reused between patients. AirFit F20 NM Mask System: The AirFit F20 Non Magnetic mask has two product variants: • The AirFit F20 Non Magnetic variant is intended for single-patient reuse in the home environment. • The AirFit F20 Non Magnetic SLM (Sleep Lab Mask) variant is intended for multi-patient reuse in the hospital/institutional environment. This mask is for patients weighing more than 66 lb (30 kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. The Sleep Lab Mask is the only variant that is validated and intended for multi-patient reprocessing and must be reprocessed if reused between patients.

Source page: https://510kreport.com/device/K242547
Methodology: https://510kreport.com/methodology