# K223747: Whitsundays Mask System

- Pathway: 510(k) (Traditional)
- Applicant: Resmed Pty Ltd (Registration Number: 3004604967)
- Decided: Jul 6, 2023 after 204 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: 13 generations back to K982530 (1998). 39 ancestors in all.
No later device cites it as a predicate yet.
3 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180497: Scone Mask, Resmed, Ltd. (2018) Summary page 4.

## Indications for use
The Whitsundays Mask System has two product variants: • Whitsundays mask • Whitsundays SLM (Sleep Lab Mask) Both masks are intended 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 Whitsundays mask is intended for single-patient reuse in the home environment and the Whitsundays SLM is intended for multi-patient reuse in the hospital/institutional environment. The Sleep Lab Mask (SLM) 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/K223747
Methodology: https://510kreport.com/methodology