# K081321: Modification to Mirage Micro

- Pathway: 510(k) (Special)
- Applicant: Resmed, Ltd.
- Decided: Oct 9, 2008 after 150 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). 17 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 20 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.

## Most influential descendants
- K090490: Mirage Echo (2009), 1 descendant of its own
- K093124: Puresom Nasal Mask-Small, Puresom Nasal Mask-Medium, Puresom Nasal Mask-Large, Models 11924-01, 11924-02, 11924-03 (2010), 0 descendants of its own

## Indications for use
The Mirage Micro 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 Micro is: to be used by adult patients (>661b / >30kg) for whom positive airway pressure has been prescribed. intended for single patient re-use in the home environment and multi-patient reuse in the hospital/institutional environment.

Source page: https://510kreport.com/device/K081321
Methodology: https://510kreport.com/methodology