510(k) · Cleared
ClearedMirage Vista Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Resmed, Ltd. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Aug 19, 2003 as substantially equivalent to K961783 (Resmed, Ltd., 1996) after a 139-day review. Its family tree reaches back 1 generation to 1996. 10 of the 58 devices in its family, counting itself, have a Class I recall. 56 later devices descend from it.
- Decided
- Aug 19, 2003
- Review
- 139 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K961783 (1996). 56 later devices descend from it, 2 citing it directly. 10 of the 58 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK961783 Sullivan Vpap II ST Nasal Vpap SystemResmed, Ltd. · 1996
- This deviceK031047 Mirage Vista MaskResmed, Ltd. · 2003
- Descendant · cites it directly · 53 of its ownK060105 Vpap Iii ST-a/Kidsta Mask SystemResmed, Ltd. · 2006
- Descendant · 2 generations on · 30 of its ownK063533 Bipap SynchronyRespironics, Inc. · 2007
- Descendant · 3 generations on · 28 of its ownK071509 Bipap Synchrony 2 Ventilatory Support SystemRespironics Inc., Sleep & Home Respiratory Group · 2007 · Recalled
- Descendant · 2 generations on · 20 of its ownK103167 Stellar 150Resmed Germany, Inc. · 2011
- Descendant · 2 generations on · 13 of its ownK063540 Bipap AutosvRespironics, Inc. · 2007
Showing 5 of 56 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 56 · See all- K060105Vpap Iii ST-a/Kidsta Mask SystemResmed, Ltd. · 2006 · cites it directly53descendants
- K063533Bipap SynchronyRespironics, Inc. · 2007 · 2 generations on30descendants
- K071509Bipap Synchrony 2 Ventilatory Support SystemRespironics Inc., Sleep & Home Respiratory Group · 2007 · 3 generations on28descendants
- K103167Stellar 150Resmed Germany, Inc. · 2011 · 2 generations on20descendants
- K063540Bipap AutosvRespironics, Inc. · 2007 · 2 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961783 | Sullivan Vpap II ST Nasal Vpap System | Resmed, Ltd. | 1996 | — |
| 0 (this device) | K031047 | Mirage Vista Mask | Resmed, Ltd. | 2003 | — |
| +1 | K060105 | Vpap Iii ST-a/Kidsta Mask System | Resmed, Ltd. | 2006 | — |
| +2 | K063533 | Bipap Synchrony | Respironics, Inc. | 2007 | — |
| +3 | K071509 | Bipap Synchrony 2 Ventilatory Support System | Respironics Inc., Sleep & Home Respiratory Group | 2007 | 2 |
| +2 | K103167 | Stellar 150 | Resmed Germany, Inc. | 2011 | — |
| +2 | K063540 | Bipap Autosv | Respironics, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 6 | 2 |
| 2010 | 6 | 1 |
| 2011 | 5 | 2 |
| 2012 | 10 | 2 |
| 2013 | 3 | 1 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 1 |
| 2020 | 2 | 0 |
| 2021 | 1 | 1 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
10 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BZD device
- #1 K250624 myAirscore 15.7 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K961783 | Sullivan Vpap II ST Nasal Vpap SystemSummary page 1…vice Trade Name: Mirage VistaTMMask Device Common Name/ Nasal Mask Classification Name: Predicate Devices: Modular Nasal Mask K961783 Device Description: The Mirage VistaTMmask has an unobtrusive design, which increases the patient’s field of vision and allow… | 1996 |
What descends from it? (56)
See all 562 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (10 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K090539Bipap Autosv AdvancedRespironics Inc., Sleep & Home Respiratory Group · 2009 · 3 generations on · ◆ in the 2009 descendants bar of FIG. 12 Class I recalls
- K090248Bipap AutosvRespironics Inc., Sleep & Home Respiratory Group · 2009 · 3 generations on · ◆ in the 2009 descendants bar of FIG. 14 Class I recalls
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 15 Class I recalls
- K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · 4 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
- K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 13 Class I recalls
- K122715Stellar 150Resmed Germany, Inc. · 2013 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K102465Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K111378Oximetry Interface KitPhilips Respironics, Inc. · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K181166Trilogy EvoRespironics, Inc. · 2019 · 5 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
Nearest 5 of 10; all are on the web page.
What does this lineage say?
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BZD
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BZD
189in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZD
8in 2023
Class I (13 since 2007) Class II/III not classified
Adverse event reports per year · BZD
60,279in 2025
MAUDE reports naming product code BZD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 21 | 83 | 29 | 65 |
| 2008 | 17 | 108 | 2 | 67 |
| 2009 | 23 | 90 | 1 | 147 |
| 2010 | 12 | 122 | 0 | 143 |
| 2011 | 23 | 125 | 1 | 189 |
| 2012 | 21 | 133 | 0 | 139 |
| 2013 | 23 | 127 | 0 | 82 |
| 2014 | 14 | 172 | 0 | 86 |
| 2015 | 11 | 224 | 0 | 114 |
| 2016 | 12 | 217 | 0 | 118 |
| 2017 | 5 | 221 | 0 | 148 |
| 2018 | 5 | 280 | 0 | 101 |
| 2019 | 6 | 231 | 4 (4) | 188 |
| 2020 | 6 | 137 | 0 | 126 |
| 2021 | 6 | 192 | 0 | 6,066 |
| 2022 | 4 | 253 | 0 | 90,768 |
| 2023 | 5 | 204 | 8 (7) | 27,987 |
| 2024 | 10 | 132 | 0 | 68,262 |
| 2025 | 7 | 189 | 0 | 60,279 |
| 2026 | 10 | 214 | 2 (2) | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031047 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031047: Mirage Vista Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031047
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026