510(k) · Cleared
ClearedMojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented Mask; Veraseal 3 Full Face AAV Non-Vented Mask
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 Jun 27, 2024 as substantially equivalent to K190533 (Sleepnet Corporation, 2019) after a 29-day review. Its family tree reaches back 7 generations to 1995. 2 of the 16 devices in its family, counting itself, have a Class I recall.
- Decided
- Jun 27, 2024
- Review
- 29 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K936047 (1995). 15 ancestors in all. No later device cites it as a predicate yet. 2 of the 16 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK936047 Spectrum (TM) MaskRespironics, Inc. · 1995
- 6 generations backK961915 Spectrum Reusable Full Face Mask - Size Petite, Small, Medium, LargeRespironics, Inc. · 1996
- 5 generations backK020759 7600 Series Reusable Full-Face Cpap/Nippv Masks Models 7620 Large…Hans Rudolph, Inc. · 2002
- 4 generations backK043382 TMS Full Advantage Full Face Mask, Models TMS-2820, TMS-2830, TMS-2840Tiara Medical Systems, Inc. · 2005
- 3 generations backK060273 Sleepnet Mojo Full Face Mask -Small, Model NO. 53835, Medium ,Model…Sleepnet Corporation · 2006
- 2 generations backK063806 Sleepnet Mojo -NV Full Face Mask, Non-VentedSleepnet Corporation · 2007 · Recalled (Class I)
- 1 generation backK190533 Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face…Sleepnet Corporation · 2019 · Recalled (Class I)
- This deviceK241520 Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented…Sleepnet Corporation · 2024
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K936047 | Spectrum (TM) Mask | Respironics, Inc. | 1995 | — |
| −6 | K961915 | Spectrum Reusable Full Face Mask - Size Petite, Small, Medium, Large | Respironics, Inc. | 1996 | — |
| −5 | K020759 | 7600 Series Reusable Full-Face Cpap/Nippv Masks Models 7620 Large, 7630… | Hans Rudolph, Inc. | 2002 | — |
| −4 | K043382 | TMS Full Advantage Full Face Mask, Models TMS-2820, TMS-2830, TMS-2840 | Tiara Medical Systems, Inc. | 2005 | — |
| −3 | K060273 | Sleepnet Mojo Full Face Mask -Small, Model NO. 53835, Medium ,Model… | Sleepnet Corporation | 2006 | — |
| −2 | K063806 | Sleepnet Mojo -NV Full Face Mask, Non-Vented | Sleepnet Corporation | 2007 | Class I |
| −1 | K190533 | Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask… | Sleepnet Corporation | 2019 | Class I |
| 0 (this device) | K241520 | Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask… | Sleepnet Corporation | 2024 | — |
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 |
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.
2 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? (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 |
|---|---|---|---|
| * | K190533 | Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full…Summary page 5…Mojo 2 Full Face Non-Vented Mask Mojo 2 AAV Non-Vented Full-Face Mask 510(k): K190533 Common/Usual Name: Patient Interface Classification Name: Continuous Ventilator… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 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.
- K190533Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented…Sleepnet Corporation · 2019 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
- K063806Sleepnet Mojo -NV Full Face Mask, Non-VentedSleepnet Corporation · 2007 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 29 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 15 ancestors have a recall of any class; 2 have a Class I recall.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Mojo 2 and Veraseal 3 Full Face Non-Vented and AAV Non-Vented Masks are 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 multi-use version. It is intended for use…
Read the full statement (110 words)
The Sleepnet Mojo 2 and Veraseal 3 Full Face Non-Vented and AAV Non-Vented Masks are 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 multi-use version. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation.
Veraseal 3 - Disposable single use (hospital/institutional)
Single patient, multi-use up to 7 days (hospital/institutional)
Mojo 2 - Single patient, multi-use (home or hospital/institutional)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241520 · printed Nov 5, 2026
Cite this page
510(k) Report. “K241520: Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented Mask; Veraseal 3 Full Face AAV Non-Vented Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K241520
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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