510(k) · Cleared
ClearedSleepnet Mojo Full Face Mask -Small, Model NO. 53835, Medium ,Model NO.53836,Large,Model NO. 53837
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 May 2, 2006 as substantially equivalent to K043382 (Tiara Medical Systems, Inc., 2005) after an 89-day review. Its family tree reaches back 4 generations to 1995. 8 of the 30 devices in its family, counting itself, have a Class I recall. 20 later devices descend from it.
- Decided
- May 2, 2006
- Review
- 89 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K936047 (1995). 9 ancestors in all. 20 later devices descend from it, 4 citing it directly. 8 of the 30 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK936047 Spectrum (TM) MaskRespironics, Inc. · 1995
- 3 generations backK961915 Spectrum Reusable Full Face Mask - Size Petite, Small, Medium, LargeRespironics, Inc. · 1996
- 2 generations backK020759 7600 Series Reusable Full-Face Cpap/Nippv Masks Models 7620 Large…Hans Rudolph, Inc. · 2002
- 1 generation backK043382 TMS Full Advantage Full Face Mask, Models TMS-2820, TMS-2830, TMS-2840Tiara Medical Systems, Inc. · 2005
- This deviceK060273 Sleepnet Mojo Full Face Mask -Small, Model NO. 53835, Medium ,Model…Sleepnet Corporation · 2006
- Descendant · cites it directly · 7 of its ownK132887 Airfit N10Resmed, Ltd. · 2013 · Recalled (Class I)
- Descendant · 2 generations on · 6 of its ownK153673 AirFit N20Resmed, Ltd. · 2016
- Descendant · cites it directly · 6 of its ownK063806 Sleepnet Mojo -NV Full Face Mask, Non-VentedSleepnet Corporation · 2007 · Recalled (Class I)
- Descendant · 3 generations on · 5 of its ownK161978 AirFit N20Resmed, Ltd. · 2016 · Recalled (Class I)
- Descendant · cites it directly · 4 of its ownK120463 Mojo, VerasealSleepnet Corporation · 2012 · Recalled (Class I)
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 20 · See all- K132887Airfit N10Resmed, Ltd. · 2013 · cites it directly7descendants
- K153673AirFit N20Resmed, Ltd. · 2016 · 2 generations on6descendants
- K063806Sleepnet Mojo -NV Full Face Mask, Non-VentedSleepnet Corporation · 2007 · cites it directly6descendants
- K161978AirFit N20Resmed, Ltd. · 2016 · 3 generations on5descendants
- K120463Mojo, VerasealSleepnet Corporation · 2012 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K936047 | Spectrum (TM) Mask | Respironics, Inc. | 1995 | — |
| −3 | K961915 | Spectrum Reusable Full Face Mask - Size Petite, Small, Medium, Large | Respironics, Inc. | 1996 | — |
| −2 | K020759 | 7600 Series Reusable Full-Face Cpap/Nippv Masks Models 7620 Large, 7630… | Hans Rudolph, Inc. | 2002 | — |
| −1 | K043382 | TMS Full Advantage Full Face Mask, Models TMS-2820, TMS-2830, TMS-2840 | Tiara Medical Systems, Inc. | 2005 | — |
| 0 (this device) | K060273 | Sleepnet Mojo Full Face Mask -Small, Model NO. 53835, Medium ,Model… | Sleepnet Corporation | 2006 | — |
| +1 | K132887 | Airfit N10 | Resmed, Ltd. | 2013 | Class I |
| +2 | K153673 | AirFit N20 | Resmed, Ltd. | 2016 | — |
| +1 | K063806 | Sleepnet Mojo -NV Full Face Mask, Non-Vented | Sleepnet Corporation | 2007 | Class I |
| +3 | K161978 | AirFit N20 | Resmed, Ltd. | 2016 | Class I |
| +1 | K120463 | Mojo, Veraseal | Sleepnet Corporation | 2012 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 1 |
| 2008 | 1 | 1 |
| 2011 | 1 | 0 |
| 2012 | 2 | 1 |
| 2013 | 1 | 1 |
| 2016 | 2 | 1 |
| 2017 | 1 | 1 |
| 2018 | 1 | 0 |
| 2019 | 2 | 2 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2026 | 2 | 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.
8 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? (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 |
|---|---|---|---|
| * | K043382 | TMS Full Advantage Full Face Mask, Models TMS-2820, TMS-2830, TMS-2840Summary page 1…Name: Nasal Mask Classification Name: Ventilator, Noncontinuous (Respirator), 73BZD Predicate devices: TMS Full Advantage TM , K043382 Reason for submission: This device has not been previously marketed in the USA. Device Description: The Sleepnet MoJo… | 2005 |
What descends from it? (20)
See all 204 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (8 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.
- K132887Airfit N10Resmed, Ltd. · 2013 · Cites it directly · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K063806Sleepnet Mojo -NV Full Face Mask, Non-VentedSleepnet Corporation · 2007 · Cites it directly · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
- K081743Classicstar NV SE and Novastar NV SE and Aav Full Face MasksDraeger Medical AG & Co. KG · 2008 · Cites it directly · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls
- K120463Mojo, VerasealSleepnet Corporation · 2012 · Cites it directly · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K190533Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented…Sleepnet Corporation · 2019 · 2 generations on · ◆ in the 2019 descendants bar of FIG. 12 Class I recalls
- K190254Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented MaskSleepnet Corporation · 2019 · 2 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
- K161978AirFit N20Resmed, Ltd. · 2016 · 3 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K171212AirFit N20Resmed, Ltd. · 2017 · 4 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
Nearest 5 of 8; all are on the web page.
What does this lineage say?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K132887 (Resmed, Ltd., 2013) has gone furthest, with 7 descendants of its own.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years.
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 MoJoTM Full Face Mask is intended to be used with positive airway pressure
devices, such as CPAP or bi-level, operating at or above 3 cm H20 for the treatment of adult
obstructive sleep apnea.
The mask is intended for single patient use and reuse in the home or hospital institutional
environment. The mask is to be used on adult patients (>30kg) for whom positive airway
pressure therapy has been prescribed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060273 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060273: Sleepnet Mojo Full Face Mask -Small, Model NO. 53835, Medium ,Model NO.53836,Large,Model NO. 53837.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060273
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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