510(k) · Cleared
ClearedModification to Mirage Micro
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 Oct 9, 2008 as substantially equivalent to K072940 (Resmed, Ltd., 2007) after a 150-day review. Its family tree reaches back 6 generations to 1998. 2 later devices descend from it.
- Decided
- Oct 9, 2008
- Review
- 150 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K982530 (1998). 17 ancestors in all, the oldest K900164 (1990). 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK982530 Sullivan Mirage Full Face MaskResmed, Ltd. · 1998
- 5 generations backK023244 Mirage Full Face Mask Series 2Resmed, Ltd. · 2002
- 4 generations backK032916 Mirage Activa MaskResmed, Ltd. · 2003
- 3 generations backK042403 Mirage SwiftResmed, Ltd. · 2004
- 2 generations backK063122 Mirage Quattro Full Face MaskResmed, Ltd. · 2007
- 1 generation backK072940 Mirage MicroResmed, Ltd. · 2007
- This deviceK081321 Modification to Mirage MicroResmed, Ltd. · 2008
- Descendant · cites it directly · 1 of its ownK090490 Mirage EchoResmed Corp · 2009
- Descendant · 2 generations on · 0 of its ownK093124 Puresom Nasal Mask-Small, Puresom Nasal Mask-Medium, Puresom Nasal…Cardinal Health 207, Inc. · 2010
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K982530 | Sullivan Mirage Full Face Mask | Resmed, Ltd. | 1998 | — |
| −5 | K023244 | Mirage Full Face Mask Series 2 | Resmed, Ltd. | 2002 | — |
| −4 | K032916 | Mirage Activa Mask | Resmed, Ltd. | 2003 | — |
| −3 | K042403 | Mirage Swift | Resmed, Ltd. | 2004 | — |
| −2 | K063122 | Mirage Quattro Full Face Mask | Resmed, Ltd. | 2007 | — |
| −1 | K072940 | Mirage Micro | Resmed, Ltd. | 2007 | — |
| 0 (this device) | K081321 | Modification to Mirage Micro | Resmed, Ltd. | 2008 | — |
| +1 | K090490 | Mirage Echo | Resmed Corp | 2009 | — |
| +2 | K093124 | Puresom Nasal Mask-Small, Puresom Nasal Mask-Medium, Puresom Nasal Mask-Large… | Cardinal Health 207, Inc. | 2010 | — |
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 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K072940 | Mirage MicroSummary page 1…ccessory to Noncontinuous Ventilator (IPPB) Classification 21 CFR 868.5905, 73 BZD (Class iI) Predicate Device Mirage Micro Mask (K072940) Description The Mirage Micro provides seal such that airflow from a p… | 2007 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090490 | Mirage Echo | 2009 | 1 |
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 10 years and passes through 1 company; a new generation was cleared every 1.0 years on median.
- None of the 17 ancestors has a recall.
- Of its descendants, K090490 (Resmed Corp, 2009) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K072940.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081321 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081321: Modification to Mirage Micro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081321
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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