# K102746: Mirage FX

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Dec 28, 2010 after 96 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: 6 generations back to K982530 (1998). 22 ancestors in all.
19 later devices descend from it; 3 cite it directly.
5 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072940: Mirage Micro, Resmed, Ltd. (2007) Summary page 1.
- K050359: Ultra Mirage II Mask, Resmed, Ltd. (2005) Summary page 1.
- K082558: Comfortlite Nasal Mask, Respironics, Inc. (2009) Summary page 1.

## Most influential descendants
- 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
- K153563: AirFit F20 (2016), 6 descendants of its own
- K153673: AirFit N20 (2016), 6 descendants of its own

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

Source page: https://510kreport.com/device/K102746
Methodology: https://510kreport.com/methodology