510(k) · Cleared
ClearedMirage Quattro
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 Jan 6, 2012 as substantially equivalent to K063122 (Resmed, Ltd., 2007) after a 74-day review. Its family tree reaches back 5 generations to 1998. 4 later devices descend from it.
- Decided
- Jan 6, 2012
- Review
- 74 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K982530 (1998). 13 ancestors in all, the oldest K900164 (1990). 4 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK982530 Sullivan Mirage Full Face MaskResmed, Ltd. · 1998
- 4 generations backK023244 Mirage Full Face Mask Series 2Resmed, Ltd. · 2002
- 3 generations backK032916 Mirage Activa MaskResmed, Ltd. · 2003
- 2 generations backK042403 Mirage SwiftResmed, Ltd. · 2004
- 1 generation backK063122 Mirage Quattro Full Face MaskResmed, Ltd. · 2007
- This deviceK113127 Mirage QuattroResmed, Ltd. · 2012
- Descendant · cites it directly · 1 of its ownK133009 Nasal Mask, Nasal Mask, Full Face MaskBMC Medical Co., Ltd. · 2014
- Descendant · 2 generations on · 0 of its ownK163464 Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)Bmc Medical., Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK150685 Skynector CPAP MaskSky Wise Medical Instrument (Shen Zhen) Co., Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK131901 Ivolve Nasal Mask, Ivolve Full Face Mask, Ivolve N23B Medical, Inc. · 2013
Most influential descendants
Showing 4 of 4 · See all- K133009Nasal Mask, Nasal Mask, Full Face MaskBMC Medical Co., Ltd. · 2014 · cites it directly1descendant
- K163464Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)Bmc Medical., Ltd. · 2017 · 2 generations on0descendants
- K150685Skynector CPAP MaskSky Wise Medical Instrument (Shen Zhen) Co., Ltd. · 2015 · cites it directly0descendants
- K131901Ivolve Nasal Mask, Ivolve Full Face Mask, Ivolve N23B Medical, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K982530 | Sullivan Mirage Full Face Mask | Resmed, Ltd. | 1998 | — |
| −4 | K023244 | Mirage Full Face Mask Series 2 | Resmed, Ltd. | 2002 | — |
| −3 | K032916 | Mirage Activa Mask | Resmed, Ltd. | 2003 | — |
| −2 | K042403 | Mirage Swift | Resmed, Ltd. | 2004 | — |
| −1 | K063122 | Mirage Quattro Full Face Mask | Resmed, Ltd. | 2007 | — |
| 0 (this device) | K113127 | Mirage Quattro | Resmed, Ltd. | 2012 | — |
| +1 | K133009 | Nasal Mask, Nasal Mask, Full Face Mask | BMC Medical Co., Ltd. | 2014 | — |
| +2 | K163464 | Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) | Bmc Medical., Ltd. | 2017 | — |
| +1 | K150685 | Skynector CPAP Mask | Sky Wise Medical Instrument (Shen Zhen) Co., Ltd. | 2015 | — |
| +1 | K131901 | Ivolve Nasal Mask, Ivolve Full Face Mask, Ivolve N2 | 3B Medical, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 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.
Planning a device in BZD? 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 |
|---|---|---|---|
| * | K063122 | Mirage Quattro Full Face MaskSummary page 1…tinuous Ventilator (IPPB) Name Classification 21 CER 868.5905, 73 BZD (Class 11) Predicate Device Mirage QuattroTM (K063122) Description The Mirage Quattro provides an interface such that airflow from a… | 2007 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 1 company; a new generation was cleared every 2.3 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K133009 (BMC Medical Co., Ltd., 2014) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K063122.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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 Quattro 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 Quattro is to be used by adult patients (>66lb 1>30kg) for whom positive airway pressure has been prescribed.
The Mirage Quattro is intended for single patient re-use in the home environment and/or multi-patient reuse in the hospital/institutional environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113127 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113127: Mirage Quattro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113127
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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