510(k) · Cleared
ClearedPixi Pediatric Mask
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 Dec 10, 2010 as substantially equivalent to K090935 (Sleepnet Corporation, 2009) after a 126-day review. Its family tree reaches back 4 generations to 1996. 3 later devices descend from it.
- Decided
- Dec 10, 2010
- Review
- 126 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K945938 (1996). 23 ancestors in all, the oldest K792018 (1979). 3 later devices descend from it, 2 citing it directly.
- 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 deviceK102224 Pixi Pediatric MaskResmed, Ltd. · 2010
- Descendant · cites it directly · 1 of its ownK120920 Hsiner Cpap Silicone Nasal Mask Size XS/Petite Hsiner Nasal Pillow…Hsiner Company · 2012
- Descendant · 2 generations on · 0 of its ownK243225 Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask -…Genadyne Biotechnologies, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK151683 SleepWeaver Advance Pediatric Nasal CPAP MaskCircadiance, LLC · 2016
Most influential descendants
Showing 3 of 3 · See all- K120920Hsiner Cpap Silicone Nasal Mask Size XS/Petite Hsiner Nasal Pillow Mask Hsiner Infant…Hsiner Company · 2012 · cites it directly1descendant
- K243225Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes…Genadyne Biotechnologies, Inc. · 2024 · 2 generations on0descendants
- K151683SleepWeaver Advance Pediatric Nasal CPAP MaskCircadiance, LLC · 2016 · cites it directly0descendants
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) | K102224 | Pixi Pediatric Mask | Resmed, Ltd. | 2010 | — |
| +1 | K120920 | Hsiner Cpap Silicone Nasal Mask Size XS/Petite Hsiner Nasal Pillow Mask Hsiner… | Hsiner Company | 2012 | — |
| +2 | K243225 | Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium… | Genadyne Biotechnologies, Inc. | 2024 | — |
| +1 | K151683 | SleepWeaver Advance Pediatric Nasal CPAP Mask | Circadiance, LLC | 2016 | — |
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 |
|---|---|---|
| 2012 | 1 | 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? (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 |
|---|---|---|---|
| * | K090935 | Minime Pediatric MaskSummary page 1…ory to Noncontinuous Ventilator (IPPB) Classification 21 CFR 868.5905, 73 BZD (Class 11) Predicate Devices MiniMe Pediatric Mask (K090935) Description The Pixi Pediatric Mask provides an interface such that airflow… | 2009 |
What descends from it? (3)
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 14 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- 2 of the 23 ancestors have a recall of any class.
- Of its descendants, K120920 (Hsiner Company, 2012) has gone furthest, with 1 descendant of its own.
- 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. 2010, 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 Pixi Pediatric mask channels airflow noninvasively to a patient from a continuous positive airway pressure (CPAP) or bilevel device.
The Pixi Pediatric mask is:
* to be used by children aged between 2 and 7 for whom continuous positive airway pressure (CPAP) or bilevel therapy has been prescribed
* intended for single-patient re-use in the home environment and single-patient re-use in the hospital/institutional environment
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102224 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102224: Pixi 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/K102224
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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