# K230476: Oran Park Mask

- Pathway: 510(k) (Traditional)
- Applicant: Resmed Pty Ltd (Registration Number: 3004604967)
- Decided: Oct 19, 2023 after 239 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: 9 generations back to K982530 (1998). 25 ancestors in all.
No later device cites it as a predicate yet.
1 of 26 devices in its family (counting itself) has a Class I recall.

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

## Indications for use
The Oran Park mask is intended for use in the home or hospital/institutional environment on patients weighing more than 66lb (30kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. Only the Sleep Lab Mask (SLM) variant is intended and validated for multi-patient reuse and must be reprocessed if reused between patients.

Source page: https://510kreport.com/device/K230476
Methodology: https://510kreport.com/methodology