510(k) · Cleared
ClearedMirage 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 Mar 16, 2011 as substantially equivalent to K072940 (Resmed, Ltd., 2007) after a 28-day review. Its family tree reaches back 6 generations to 1998.
- Decided
- Mar 16, 2011
- Review
- 28 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). No later device cites it as a predicate yet.
- 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 deviceK110444 Mirage MicroResmed, Ltd. · 2011
View 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) | K110444 | Mirage Micro | Resmed, Ltd. | 2011 | — |
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 |
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…Classification Name Accessory to Noncontinuous Ventilator (IPPB) Classification 21 CFR 868.5905, 73 220 (Class 11) Predicate Device Mirage Micro Mask (K072940) Description The headgear colour of the modified device has changed. The color of the outer la… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 13 years and passes through 1 company; a new generation was cleared every 2.3 years on median.
- None of the 17 ancestors has a recall.
- 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. 2011, 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 (OPAl') 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/instilutional environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110444 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110444: 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/K110444
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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