# K030798: Mirage Activa Mask

- Pathway: 510(k) (Special)
- Applicant: Resmed, Ltd.
- Decided: Apr 9, 2003 after 27 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: 1 generation back to K961783 (1996). 1 ancestor in all.
96 later devices descend from it; 5 cite it directly.
9 of 98 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.

## Most influential descendants
- K032916: Mirage Activa Mask (2003), 93 descendants of its own
- K042403: Mirage Swift (2004), 80 descendants of its own
- K050359: Ultra Mirage II Mask (2005), 39 descendants of its own
- K063122: Mirage Quattro Full Face Mask (2007), 38 descendants of its own
- K071808: Mirage Micro (2007), 27 descendants of its own

## Indications for use
The Mirage ActivaTMMask is an accessory to a non-continuous ventilator (respirator) intended for single-patient use for adult patients prescribed continuous positive airway pressure (CPAP) and bi-level therapy in hospital, clinic and home environments.

Source page: https://510kreport.com/device/K030798
Methodology: https://510kreport.com/methodology