# K183512: Moore Park Mask

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: May 7, 2019 after 140 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: 5 generations back to K982530 (1998). 13 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 16 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063011: Mirage Liberty Full Face Mask, Resmed, Ltd. (2007) Summary page 5.

## Most influential descendants
- K234134: AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System (2024), 1 descendant of its own
- K253166: F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) (2026), 0 descendants of its own

## Recalls of this device
- Nov 20, 2023 · Class I · Z-0542-2024: 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 Moore Park mask is intended to be used by patients weighing more than 66 lb (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/K183512
Methodology: https://510kreport.com/methodology