510(k) · Cleared
ClearedSleepWeaver Advance Pediatric Nasal CPAP Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Circadiance, LLC · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Apr 5, 2016 as substantially equivalent to K102224 (Resmed, Ltd., 2010) after a 288-day review. Its family tree reaches back 5 generations to 1996.
- Decided
- Apr 5, 2016
- Review
- 288 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K945938 (1996). 24 ancestors in all, the oldest K792018 (1979). No later device cites it as a predicate yet.
- Root · 5 generations backK945938 Respironics Monarch Mini MaskRespironics, Inc. · 1996
- 4 generations backK992336 Monarch II Mini MaskRespironics, Inc. · 1999
- 3 generations backK053352 Comfortlite Nasal MaskRespironics, Inc. · 2006
- 2 generations backK090935 Minime Pediatric MaskSleepnet Corporation · 2009
- 1 generation backK102224 Pixi Pediatric MaskResmed, Ltd. · 2010
- This deviceK151683 SleepWeaver Advance Pediatric Nasal CPAP MaskCircadiance, LLC · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K945938 | Respironics Monarch Mini Mask | Respironics, Inc. | 1996 | — |
| −4 | K992336 | Monarch II Mini Mask | Respironics, Inc. | 1999 | — |
| −3 | K053352 | Comfortlite Nasal Mask | Respironics, Inc. | 2006 | — |
| −2 | K090935 | Minime Pediatric Mask | Sleepnet Corporation | 2009 | — |
| −1 | K102224 | Pixi Pediatric Mask | Resmed, Ltd. | 2010 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K102224 | Pixi Pediatric MaskSummary page 5…sification Name Accessory to Non-Continuous Ventilator, Class II, 21 CFR 868.5905, Product Code: BZD Predicate Devices ResMed Ltd., Pixi Pediatric Mask (K102224) Indications for Use The SleepWeaver Advance Pediatric Nasal Mask is intended to provide an interface for noninvasive Positive… | 2010 |
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 20 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- 2 of the 24 ancestors have a recall of any class.
- 1 other device also cites its predicate K102224.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 SleepWeaver Advance Pediatric Nasal Mask is intended to provide an interface for noninvasive Positive Airway Pressure (PAP)
ventilation therapy. This mask is intended for single-patient use in the home and single-patient use in the hospital / institutional
environment. This mask is to be used on patients between 2 and 7 years of age.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151683 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151683: SleepWeaver Advance Pediatric Nasal CPAP Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151683
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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