# K031047: Mirage Vista Mask

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Aug 19, 2003 after 139 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: 1 generation back to K961783 (1996). 1 ancestor in all.
56 later devices descend from it; 2 cite it directly.
10 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961783: Sullivan Vpap II ST Nasal Vpap System, Resmed, Ltd. (1996) Summary page 1.

## Most influential descendants
- K060105: Vpap Iii ST-a/Kidsta Mask System (2006), 53 descendants of its own
- K063533: Bipap Synchrony (2007), 30 descendants of its own
- K071509: Bipap Synchrony 2 Ventilatory Support System (2007), 28 descendants of its own
- K103167: Stellar 150 (2011), 20 descendants of its own
- K063540: Bipap Autosv (2007), 13 descendants of its own

## Indications for use
The Mirage VistaTMmask is an accessory to a noncontinuous ventilator (respirator), intended for multiple-patient use for adult patients prescribed continuous positive airway pressure (CPAP) and bi-level therapy in hospital, clinical, and home environments.

Source page: https://510kreport.com/device/K031047
Methodology: https://510kreport.com/methodology