# K063122: Mirage Quattro Full Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Feb 2, 2007 after 113 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: 4 generations back to K982530 (1998). 12 ancestors in all.
38 later devices descend from it; 7 cite it directly.
7 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023244: 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.
- K023306: Mirage Full Face Mask Series 2, Resmed, Ltd. (2002) Summary page 1.
- K042403: Mirage Swift, Resmed, Ltd. (2004) Summary page 1.

## Most influential descendants
- K072940: Mirage Micro (2007), 26 descendants of its own
- K102746: Mirage FX (2010), 19 descendants of its own
- K123979: Quattro Air (2013), 9 descendants of its own
- K123789: Swift FX Nano (2013), 8 descendants of its own
- K132887: Airfit N10 (2013), 7 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 (>661b / >30kg) for whom positive airway pressure has been prescribed. The Mirage Quattro FFM 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/K063122
Methodology: https://510kreport.com/methodology