# K180497: Scone Mask

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Jun 15, 2018 after 109 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). 38 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171212: AirFit N20, Resmed, Ltd. (2017) Summary page 4.

## Most influential descendants
- K223747: Whitsundays Mask System (2023), 0 descendants of its own

## Indications for use
The Scone Mask is intended to be used by patients weighing more than 66 1b (30 kg) who have been prescribed non-invasive positive airway pressure (PAP) therapy such as CPAP or bi-level therapy. The mask is intended for single patient re-use in the home and multi-patient re-use in the hospital/institutional environment.

Source page: https://510kreport.com/device/K180497
Methodology: https://510kreport.com/methodology