510(k) · Cleared
ClearedMinime 2 Nasal Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sleepnet Corporation · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Nov 5, 2012 as substantially equivalent to K090935 (Sleepnet Corporation, 2009) and 1 other predicate after a 151-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Nov 5, 2012
- Review
- 151 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K945938 (1996). 23 ancestors in all, the oldest K792018 (1979). No later device cites it as a predicate yet.
- Root · 4 generations backK945938 Respironics Monarch Mini MaskRespironics, Inc. · 1996
- 3 generations backK992336 Monarch II Mini MaskRespironics, Inc. · 1999
- 2 generations backK053352 Comfortlite Nasal MaskRespironics, Inc. · 2006
- 1 generation backK090935 Minime Pediatric MaskSleepnet Corporation · 2009
- This deviceK121692 Minime 2 Nasal MaskSleepnet Corporation · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K945938 | Respironics Monarch Mini Mask | Respironics, Inc. | 1996 | — |
| −3 | K992336 | Monarch II Mini Mask | Respironics, Inc. | 1999 | — |
| −2 | K053352 | Comfortlite Nasal Mask | Respironics, Inc. | 2006 | — |
| −1 | K090935 | Minime Pediatric Mask | Sleepnet Corporation | 2009 | — |
| 0 (this device) | K121692 | Minime 2 Nasal Mask | Sleepnet Corporation | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 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? (2)
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 |
|---|---|---|---|
| * | K090935 | Minime Pediatric MaskSummary page 1…2I1CFR 868.5905 Class 2 Device: MiniMe 2 Nasal Mask Predicate Devices: K090935 - SleepNet MiniMe pediatric nasal mask K060105 - ResMed Kidsta Pediatric Mask Device Description:… | 2009 |
| * | K060105 | Vpap Iii ST-a/Kidsta Mask SystemSummary page 1…ss 2 Device: MiniMe 2 Nasal Mask Predicate Devices: K090935 - SleepNet MiniMe pediatric nasal mask K060105 - ResMed Kidsta Pediatric Mask Device Description: The MiniMe 2 Nasal mask is intended to provide a patient interface for applica… | 2006 |
| † | K102317 | IQ Ventilation Nasal Mask | 2011 |
| † | K993269 | IQ Nasal Mask, Model P/N 50160 | 1999 |
| † | K021534 | IQ Nasal Mask, Model 50160 Rev. D | 2002 |
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 16 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- 2 of the 23 ancestors have a recall of any class.
- 1 other device also cites its predicate K090935.
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 MiniMe 2 Nasal mask is intended to provide a patient interface for application of positive pressure therapy. The mask is to be used as an accessory to CPAP or Bi-level positive pressure systems. It is intended for patients >2 years old and <12 years old.
The mask is designed and labeled for different durations of use:
* Single use, disposable (hospital or institutional settings)
* Single patient, multi-use (home setting)
* Single patient, short-term use up to 7 days (hospital or institutional settings)
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K121692 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121692: Minime 2 Nasal Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121692
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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