# K050359: Ultra Mirage II Mask

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Mar 16, 2005 after 30 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: 3 generations back to K982530 (1998). 8 ancestors in all.
39 later devices descend from it; 13 cite it directly.
5 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961783: Sullivan Vpap II ST Nasal Vpap System, Resmed, Ltd. (1996) Summary page 1.
- K032916: Mirage Activa Mask, Resmed, Ltd. (2003) Summary page 1.

## Most influential descendants
- K071808: Mirage Micro (2007), 27 descendants of its own
- K072940: Mirage Micro (2007), 26 descendants of its own
- K102746: Mirage FX (2010), 19 descendants of its own
- K073638: Swift LT (2008), 17 descendants of its own
- K090244: Swift FX (2009), 15 descendants of its own

## Indications for use
The Ultra Mirage II Mask is intended for multipatient re-use for adult patients prescribed continuous positive airway pressure (CPAP) or bilevel therapy in hospitals, clinic and home environments.

Source page: https://510kreport.com/device/K050359
Methodology: https://510kreport.com/methodology