510(k) · Cleared
ClearedSleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented 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 Jan 15, 2026 as substantially equivalent to K153563 (Resmed, Ltd., 2016) and 1 other predicate after a 213-day review. Its family tree reaches back 12 generations to 1998. 4 of the 41 devices in its family, counting itself, have a Class I recall.
- Decided
- Jan 15, 2026
- Review
- 213 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K982530 (1998). 40 ancestors in all, the oldest K900164 (1990). No later device cites it as a predicate yet. 4 of the 41 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK982530 Sullivan Mirage Full Face MaskResmed, Ltd. · 1998
- 8 generations between
- 3 generations backK153673 AirFit N20Resmed, Ltd. · 2016
- 2 generations backK161978 AirFit N20Resmed, Ltd. · 2016 · Recalled (Class I)
- 1 generation backK171212 AirFit N20Resmed, Ltd. · 2017 · Recalled (Class I)
- This deviceK251847 Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented MaskSleepnet Corporation · 2026
Show all 12 generations
- Root · 12 generations backK982530 Sullivan Mirage Full Face MaskResmed, Ltd. · 1998
- 11 generations backK023244 Mirage Full Face Mask Series 2Resmed, Ltd. · 2002
- 10 generations backK032916 Mirage Activa MaskResmed, Ltd. · 2003
- 9 generations backK042403 Mirage SwiftResmed, Ltd. · 2004
- 8 generations backK063122 Mirage Quattro Full Face MaskResmed, Ltd. · 2007
- 7 generations backK072940 Mirage MicroResmed, Ltd. · 2007
- 6 generations backK102746 Mirage FXResmed, Ltd. · 2010
- 5 generations backK123789 Swift FX NanoResmed, Ltd. · 2013
- 4 generations backK132887 Airfit N10Resmed, Ltd. · 2013 · Recalled (Class I)
- 3 generations backK153673 AirFit N20Resmed, Ltd. · 2016
- 2 generations backK161978 AirFit N20Resmed, Ltd. · 2016 · Recalled (Class I)
- 1 generation backK171212 AirFit N20Resmed, Ltd. · 2017 · Recalled (Class I)
- This deviceK251847 Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented MaskSleepnet Corporation · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K982530 | Sullivan Mirage Full Face Mask | Resmed, Ltd. | 1998 | — |
| −11 | K023244 | Mirage Full Face Mask Series 2 | Resmed, Ltd. | 2002 | — |
| −10 | K032916 | Mirage Activa Mask | Resmed, Ltd. | 2003 | — |
| −9 | K042403 | Mirage Swift | Resmed, Ltd. | 2004 | — |
| −8 | K063122 | Mirage Quattro Full Face Mask | Resmed, Ltd. | 2007 | — |
| −7 | K072940 | Mirage Micro | Resmed, Ltd. | 2007 | — |
| −6 | K102746 | Mirage FX | Resmed, Ltd. | 2010 | — |
| −5 | K123789 | Swift FX Nano | Resmed, Ltd. | 2013 | — |
| −4 | K132887 | Airfit N10 | Resmed, Ltd. | 2013 | Class I |
| −3 | K153673 | AirFit N20 | Resmed, Ltd. | 2016 | — |
| −2 | K161978 | AirFit N20 | Resmed, Ltd. | 2016 | Class I |
| −1 | K171212 | AirFit N20 | Resmed, Ltd. | 2017 | Class I |
| 0 (this device) | K251847 | Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask | Sleepnet Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 1 |
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.
4 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K153563 | AirFit F20Summary page 5…(IPPB) Class: II Product Codes: BZD 510(k) Number: K251847 Primary Predicate: AirFit F20 Full Face Mask, K153563 (for Arie Full Face Vented Mask) AirFit N20 Nasal Mask, K171212 (for Ar… | 2016 |
| * | K171212 | AirFit N20Summary page 5…Predicate: AirFit F20 Full Face Mask, K153563 (for Arie Full Face Vented Mask) AirFit N20 Nasal Mask, K171212 (for Arie Nasal Vented Mask) Reference Device: F&P Evora Full Face Mask, K212371 (for Ar… | 2017 |
| † | K212371 | F&P Evora Full Face Mask | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (4 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K171212AirFit N20Resmed, Ltd. · 2017 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K153563AirFit F20Resmed, Ltd. · 2016 · Direct predicate · ◆ in the 2016 ancestors bar of FIG. 11 Class I recall
- K161978AirFit N20Resmed, Ltd. · 2016 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K132887Airfit N10Resmed, Ltd. · 2013 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 28 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
- 5 of the 40 ancestors have a recall of any class; 4 have a Class I recall.
- 2 other devices also cite its predicate K153563.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Sleepnet Arie Full Face Vented Mask is intended to be used with positive airway pressure devices, such as CPAP or bi-level, operating at or above 4 cm H2O. The mask is to be used on adult patients (>30kg) for whom positive airway pressure therapy has been prescribed. The mask is intended for single-patient multi-use in the home, hospital, or institutional environment. The Sleepnet Arie Nasal Vented Mask is intended to be used with positive airway…
Read the full statement (123 words)
The Sleepnet Arie Full Face Vented Mask is intended to be used with positive airway pressure devices, such as CPAP or bi-level, operating at or above 4 cm H2O. The mask is to be used on adult patients (>30kg) for whom positive airway pressure therapy has been prescribed. The mask is intended for single-patient multi-use in the home, hospital, or institutional environment.
The Sleepnet Arie Nasal Vented Mask is intended to be used with positive airway pressure devices, such as CPAP or bi-level, operating at or above 4 cm H2O. The mask is to be used on adult patients (>30kg) for whom positive airway pressure therapy has been prescribed. The mask is intended for single-patient multi-use in the home, hospital, or institutional environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251847 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251847: Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251847
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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