# K251847: Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask

- Pathway: 510(k) (Traditional)
- Applicant: Sleepnet Corporation
- Decided: Jan 15, 2026 after 213 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: 12 generations back to K982530 (1998). 40 ancestors in all.
No later device cites it as a predicate yet.
4 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153563: AirFit F20, Resmed, Ltd. (2016) Summary page 5.
- K171212: AirFit N20, Resmed, Ltd. (2017) Summary page 5.

## Indications for use
The Sleepnet Arie Full Face Vented Mask is intended to be used with positive airway pressure devices, such as CPAP or bi-level, operating at or above 4 cm H2O. The mask is to be used on adult patients (>30kg) for whom positive airway pressure therapy has been prescribed. The mask is intended for single-patient multi-use in the home, hospital, or institutional environment. The Sleepnet Arie Nasal Vented Mask is intended to be used with positive airway pressure devices, such as CPAP or bi-level, operating at or above 4 cm H2O. The mask is to be used on adult patients (>30kg) for whom positive airway pressure therapy has been prescribed. The mask is intended for single-patient multi-use in the home, hospital, or institutional environment.

Source page: https://510kreport.com/device/K251847
Methodology: https://510kreport.com/methodology