510(k) · Cleared
Recalled · Class I · 2024Sleepnet Mojo -NV Full Face Mask, Non-Vented
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sleepnet Corporation · CBK Ventilator, Continuous, Facility Use
Cleared on May 17, 2007 as substantially equivalent to K060273 (Sleepnet Corporation, 2006) and 1 other predicate after a 146-day review. Its family tree reaches back 5 generations to 1995. 3 of the 20 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- May 17, 2007
- Review
- 146 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 1 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 5 generations to K936047 (1995). 13 ancestors in all. 6 later devices descend from it, 3 citing it directly. 3 of the 20 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK936047 Spectrum (TM) MaskRespironics, Inc. · 1995
- 4 generations backK961915 Spectrum Reusable Full Face Mask - Size Petite, Small, Medium, LargeRespironics, Inc. · 1996
- 3 generations backK020759 7600 Series Reusable Full-Face Cpap/Nippv Masks Models 7620 Large…Hans Rudolph, Inc. · 2002
- 2 generations backK043382 TMS Full Advantage Full Face Mask, Models TMS-2820, TMS-2830, TMS-2840Tiara Medical Systems, Inc. · 2005
- 1 generation backK060273 Sleepnet Mojo Full Face Mask -Small, Model NO. 53835, Medium ,Model…Sleepnet Corporation · 2006
- This deviceK063806 Sleepnet Mojo -NV Full Face Mask, Non-VentedSleepnet Corporation · 2007
- Descendant · cites it directly · 2 of its ownK102317 IQ Ventilation Nasal MaskSleepnet Corporation · 2011
- Descendant · cites it directly · 1 of its ownK190533 Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face…Sleepnet Corporation · 2019 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK241520 Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented…Sleepnet Corporation · 2024
- Descendant · 2 generations on · 0 of its ownK203601 Innova Nasal Non-Vented MaskSleepnet Corporation · 2021
- Descendant · 2 generations on · 0 of its ownK121321 Hard Shell Vented Nasal MaskSleepnet Corporation · 2012
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 6 · See all- K102317IQ Ventilation Nasal MaskSleepnet Corporation · 2011 · cites it directly2descendants
- K190533Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full…Sleepnet Corporation · 2019 · cites it directly1descendant
- K241520Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full…Sleepnet Corporation · 2024 · 2 generations on0descendants
- K203601Innova Nasal Non-Vented MaskSleepnet Corporation · 2021 · 2 generations on0descendants
- K121321Hard Shell Vented Nasal MaskSleepnet Corporation · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K936047 | Spectrum (TM) Mask | Respironics, Inc. | 1995 | — |
| −4 | K961915 | Spectrum Reusable Full Face Mask - Size Petite, Small, Medium, Large | Respironics, Inc. | 1996 | — |
| −3 | K020759 | 7600 Series Reusable Full-Face Cpap/Nippv Masks Models 7620 Large, 7630… | Hans Rudolph, Inc. | 2002 | — |
| −2 | K043382 | TMS Full Advantage Full Face Mask, Models TMS-2820, TMS-2830, TMS-2840 | Tiara Medical Systems, Inc. | 2005 | — |
| −1 | K060273 | Sleepnet Mojo Full Face Mask -Small, Model NO. 53835, Medium ,Model… | Sleepnet Corporation | 2006 | — |
| 0 (this device) | K063806 | Sleepnet Mojo -NV Full Face Mask, Non-Vented | Sleepnet Corporation | 2007 | — |
| +1 | K102317 | IQ Ventilation Nasal Mask | Sleepnet Corporation | 2011 | — |
| +1 | K190533 | Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask… | Sleepnet Corporation | 2019 | Class I |
| +2 | K241520 | Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask… | Sleepnet Corporation | 2024 | — |
| +2 | K203601 | Innova Nasal Non-Vented Mask | Sleepnet Corporation | 2021 | — |
| +2 | K121321 | Hard Shell Vented Nasal Mask | Sleepnet Corporation | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 1 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2019 | 1 | 1 |
| 2021 | 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.
3 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 CBK device
- #1 K252663 Inbentus Versatilescore 16.0 · 17 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 |
|---|---|---|---|
| * | K060273 | Sleepnet Mojo Full Face Mask -Small, Model NO. 53835, Medium ,Model NO.53836,Large,Model…Summary page 1…Face Mask Classification Name: Ventilator, Noncontinuous (Respirator), 73CBK Predicate devices: SleepNet MoJoTM -NV Full Face Mask, K060273 Respcare Hybrid NE Mask, K062019 Reason for submission: This device has not been pre… | 2006 |
| * | K062019 | Respcare Hybrid NE Face Mask, Model TBD,; Disposable, Model TBDSummary page 1…oncontinuous (Respirator), 73CBK Predicate devices: SleepNet MoJoTM -NV Full Face Mask, K060273 Respcare Hybrid NE Mask, K062019 Reason for submission: This device has not been previously marketed in the USA. Device Description: The Sleepnet MoJoT… | 2006 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 1, 2024 | Class I | Z-1352-2024 | Device Design | Update to contraindications and warning language due to CPAP masks containing magnets. |
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.
- K190533Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented…Sleepnet Corporation · 2019 · Cites it directly · ◆ in the 2019 descendants bar of FIG. 12 Class I recalls
- 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
What does this lineage say?
- The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K102317 (Sleepnet Corporation, 2011) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K060273.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · CBK
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CBK
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CBK
14in 2024
Class I (81 since 2007) Class II/III not classified
Adverse event reports per year · CBK
13,991in 2025
MAUDE reports naming product code CBK, 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 | 11 | 142 | 17 | 1,531 |
| 2008 | 18 | 115 | 23 | 1,933 |
| 2009 | 12 | 122 | 8 | 1,766 |
| 2010 | 14 | 150 | 9 | 1,799 |
| 2011 | 13 | 192 | 12 | 1,877 |
| 2012 | 17 | 207 | 2 (1) | 5,509 |
| 2013 | 5 | 277 | 5 (2) | 7,921 |
| 2014 | 5 | 439 | 5 (4) | 7,600 |
| 2015 | 7 | 266 | 6 (4) | 11,876 |
| 2016 | 4 | 323 | 4 (1) | 16,056 |
| 2017 | 6 | 280 | 1 | 14,451 |
| 2018 | 4 | 183 | 3 (3) | 9,849 |
| 2019 | 8 | 435 | 14 (13) | 9,100 |
| 2020 | 5 | 176 | 4 | 11,096 |
| 2021 | 6 | 267 | 21 (19) | 13,322 |
| 2022 | 0 | — | 8 (4) | 15,974 |
| 2023 | 5 | 309 | 4 (3) | 24,928 |
| 2024 | 9 | 203 | 14 (14) | 20,336 |
| 2025 | 4 | 163 | 0 | 13,991 |
| 2026 | 3 | 235 | 15 (13) | — |
What is it indicated for?
The Sleepnet MoJoTM-NV Full Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure, and which are intended to administer positive pressure ventilation. The mask will be offered in a disposable version and a multiuse version. It is intended for use on adult patients (>30 kg), who are…
Read the full statement (141 words)
The Sleepnet MoJoTM-NV Full Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure, and which are intended to administer positive pressure ventilation. The mask will be offered in a disposable version and a multiuse version. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation.
(Applies to the standard version):
For homecare applications, the Sleepnet MoJoTM-NV Full Face Mask, Nonvented may be reused multiple times by a single patient. For institutional applications (i.e. hospital or other clinical settings), this interface may be reused multiple times by multiple patients.
(Applies to the disposable version):
The Sleepnet MoJoTM-NV Full Face Mask, Nonvented Disposable is a single patient, single use interface.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063806 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063806: Sleepnet Mojo -NV Full Face Mask, Non-Vented.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063806
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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