# K171212: AirFit N20

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Sep 28, 2017 after 156 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K982530 (1998). 37 ancestors in all.
3 later devices descend from it; 2 cite it directly.
3 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161978: AirFit N20, Resmed, Ltd. (2016) Summary page 4.

## Most influential descendants
- K180497: Scone Mask (2018), 1 descendant of its own
- K251847: Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask (2026), 0 descendants of its own
- K223747: Whitsundays Mask System (2023), 0 descendants of its own

## Recalls of this device
- Nov 20, 2023 · Class I · Z-0539-2024: Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/ob

## Indications for use
The AirFit N20 channels airflow non-invasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel device. The AirFit N20 is: • to be used by patients weighing more than 66 lb (30 kg) for whom positive airway pressure has been prescribed • intended for single patient re-use in the home environment and multi-patient re-use in the hospital/institutional environment.

Source page: https://510kreport.com/device/K171212
Methodology: https://510kreport.com/methodology