510(k) · Cleared
ClearedMinime Pediatric 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 Jul 1, 2009 as substantially equivalent to K073600 (Respironics Inc., Sleep & Home Respiratory Group, 2008) and 5 other predicates after a 90-day review. Its family tree reaches back 3 generations to 1996. 5 later devices descend from it.
- Decided
- Jul 1, 2009
- Review
- 90 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 3 generations to K945938 (1996). 22 ancestors in all, the oldest K792018 (1979). 5 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK945938 Respironics Monarch Mini MaskRespironics, Inc. · 1996
- 2 generations backK992336 Monarch II Mini MaskRespironics, Inc. · 1999
- 1 generation backK053352 Comfortlite Nasal MaskRespironics, Inc. · 2006
- This deviceK090935 Minime Pediatric MaskSleepnet Corporation · 2009
- Descendant · cites it directly · 3 of its ownK102224 Pixi Pediatric MaskResmed, Ltd. · 2010
- Descendant · 2 generations on · 1 of its ownK120920 Hsiner Cpap Silicone Nasal Mask Size XS/Petite Hsiner Nasal Pillow…Hsiner Company · 2012
- Descendant · 3 generations on · 0 of its ownK243225 Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask -…Genadyne Biotechnologies, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK151683 SleepWeaver Advance Pediatric Nasal CPAP MaskCircadiance, LLC · 2016
- Descendant · cites it directly · 0 of its ownK121692 Minime 2 Nasal MaskSleepnet Corporation · 2012
Most influential descendants
Showing 5 of 5 · See all- K102224Pixi Pediatric MaskResmed, Ltd. · 2010 · cites it directly3descendants
- K120920Hsiner Cpap Silicone Nasal Mask Size XS/Petite Hsiner Nasal Pillow Mask Hsiner Infant…Hsiner Company · 2012 · 2 generations on1descendant
- K243225Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes…Genadyne Biotechnologies, Inc. · 2024 · 3 generations on0descendants
- K151683SleepWeaver Advance Pediatric Nasal CPAP MaskCircadiance, LLC · 2016 · 2 generations on0descendants
- K121692Minime 2 Nasal MaskSleepnet Corporation · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945938 | Respironics Monarch Mini Mask | Respironics, Inc. | 1996 | — |
| −2 | K992336 | Monarch II Mini Mask | Respironics, Inc. | 1999 | — |
| −1 | K053352 | Comfortlite Nasal Mask | Respironics, Inc. | 2006 | — |
| 0 (this device) | K090935 | Minime Pediatric Mask | Sleepnet Corporation | 2009 | — |
| +1 | K102224 | Pixi Pediatric Mask | Resmed, Ltd. | 2010 | — |
| +2 | K120920 | Hsiner Cpap Silicone Nasal Mask Size XS/Petite Hsiner Nasal Pillow Mask Hsiner… | Hsiner Company | 2012 | — |
| +3 | K243225 | Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium… | Genadyne Biotechnologies, Inc. | 2024 | — |
| +2 | K151683 | SleepWeaver Advance Pediatric Nasal CPAP Mask | Circadiance, LLC | 2016 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2016 | 1 | 0 |
| 2024 | 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? (6)
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 |
|---|---|---|---|
| * | K073600 | Comfortgel Full Face MaskSummary page 1…n-continuous (respirator) CFR 868.5905 Device: MiniMeTM Pediatric Mask Predicate Devices: K073600 / K954207 - Respironics CornfortGel K053352 -Respironics ComfortLite2… | 2008 |
| * | K954207 | Gel MaskSummary page 1…us (respirator) CFR 868.5905 Device: MiniMeTM Pediatric Mask Predicate Devices: K073600 / K954207 - Respironics CornfortGel K053352 -Respironics ComfortLite2… | 1996 |
| * | K053352 | Comfortlite Nasal MaskSummary page 1…ce: MiniMeTM Pediatric Mask Predicate Devices: K073600 / K954207 - Respironics CornfortGel K053352 -Respironics ComfortLite2 K032922 - Airway Development Clarissa… | 2006 |
| * | K032922 | Clarissa Infant Ncpap CannulaSummary page 1…ices: K073600 / K954207 - Respironics CornfortGel K053352 -Respironics ComfortLite2 K032922 - Airway Development Clarissa K060 105 - ResMed Kidsta KO01… | 2004 |
| * | K060105 | Vpap Iii ST-a/Kidsta Mask SystemSummary page 1…K053352 -Respironics ComfortLite2 K032922 - Airway Development Clarissa K060 105 - ResMed Kidsta KO013 306 - S leepNet MiniMe Device Description: The SleepNet MiniMeTM Pediat… | 2006 |
| * | K013306 | Minime Nasal Mask, Model P/N 50220Summary page 2…Page 2 of 2 18-Jun-09 Technology - · Identical technology to - SleepNet MiniMeT M - K013306 Materials - * The materials in patient contact identical to predicate devices Environment of Use - * Identical to pred… | 2001 |
What descends from it? (5)
2 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 13 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- 2 of the 22 ancestors have a recall of any class.
- Of its descendants, K102224 (Resmed, Ltd., 2010) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K073600.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 MiniMeTM Pediatric Mask is intended to provide an interface for application of CPAP or bi-level therapy. It is intended for patients > 2 years old and < 12 years old.
The MiniMe Pediatric Mask is intended for single patient, multi-use in the home environment and multiple patients, multi-use in the hospital/ institutional environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090935 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090935: Minime Pediatric Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090935
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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