# K032916: Mirage Activa Mask

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Dec 4, 2003 after 73 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: 2 generations back to K982530 (1998). 7 ancestors in all.
93 later devices descend from it; 4 cite it directly.
9 of 101 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030798: Mirage Activa Mask, Resmed, Ltd. (2003) Summary page 1.
- K023244: Mirage Full Face Mask Series 2, Resmed, Ltd. (2002) Summary page 1.
- K023306: Mirage Full Face Mask Series 2, Resmed, Ltd. (2002) Summary page 1.
- K023284: Mirage Full Face Mask Series 2, Resmed, Ltd. (2002) Summary page 1.
- K961783: Sullivan Vpap II ST Nasal Vpap System, Resmed, Ltd. (1996) Summary page 1.

## Most influential descendants
- 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
- K072940: Mirage Micro (2007), 26 descendants of its own

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

Source page: https://510kreport.com/device/K032916
Methodology: https://510kreport.com/methodology