# K100772: Mirage Micro Model 16333 (S), 16334 (M&L), 16335 (LW & XL)

- Pathway: 510(k) (Special)
- Applicant: Resmed, Ltd.
- Decided: Jun 9, 2010 after 83 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## 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 (CRAP) or bilevel system. The Mirage Micro is: - to be used by adult patients (>661b I >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/K100772
Methodology: https://510kreport.com/methodology