# K113127: Mirage Quattro

- Pathway: 510(k) (Special)
- Applicant: Resmed, Ltd.
- Decided: Jan 6, 2012 after 74 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: 5 generations back to K982530 (1998). 13 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063122: Mirage Quattro Full Face Mask, Resmed, Ltd. (2007) Summary page 1.

## Most influential descendants
- K133009: Nasal Mask, Nasal Mask, Full Face Mask (2014), 1 descendant of its own
- K163464: Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) (2017), 0 descendants of its own
- K150685: Skynector CPAP Mask (2015), 0 descendants of its own
- K131901: Ivolve Nasal Mask, Ivolve Full Face Mask, Ivolve N2 (2013), 0 descendants of its own

## Indications for use
The Mirage Quattro channels airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bilevel system. The Mirage Quattro is to be used by adult patients (>66lb 1>30kg) for whom positive airway pressure has been prescribed. The Mirage Quattro is intended for single patient re-use in the home environment and/or multi-patient reuse in the hospital/institutional environment.

Source page: https://510kreport.com/device/K113127
Methodology: https://510kreport.com/methodology