510(k) · Cleared
ClearedMojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face 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 Oct 18, 2024 as substantially equivalent to K120463 (Sleepnet Corporation, 2012) after a 116-day review. Its family tree reaches back 6 generations to 1995. 1 of the 24 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Oct 18, 2024
- Review
- 116 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K936047 (1995). 22 ancestors in all, the oldest K900164 (1990). 1 later device descends from it, 1 citing it directly. 1 of the 24 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK936047 Spectrum (TM) MaskRespironics, Inc. · 1995
- 5 generations backK961915 Spectrum Reusable Full Face Mask - Size Petite, Small, Medium, LargeRespironics, Inc. · 1996
- 4 generations backK020759 7600 Series Reusable Full-Face Cpap/Nippv Masks Models 7620 Large…Hans Rudolph, Inc. · 2002
- 3 generations backK043382 TMS Full Advantage Full Face Mask, Models TMS-2820, TMS-2830, TMS-2840Tiara Medical Systems, Inc. · 2005
- 2 generations backK060273 Sleepnet Mojo Full Face Mask -Small, Model NO. 53835, Medium ,Model…Sleepnet Corporation · 2006
- 1 generation backK120463 Mojo, VerasealSleepnet Corporation · 2012 · Recalled (Class I)
- This deviceK241830 Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova…Sleepnet Corporation · 2024
- Descendant · cites it directly · 0 of its ownK251920 Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask…Dcstar, Inc. · 2026
Class I recalls in this family
- K120463 Mojo, Verasealdirect predicate · 2012
Most influential descendants
Showing 1 of 1 · See all- K251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face…Dcstar, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K936047 | Spectrum (TM) Mask | Respironics, Inc. | 1995 | — |
| −5 | K961915 | Spectrum Reusable Full Face Mask - Size Petite, Small, Medium, Large | Respironics, Inc. | 1996 | — |
| −4 | K020759 | 7600 Series Reusable Full-Face Cpap/Nippv Masks Models 7620 Large, 7630… | Hans Rudolph, Inc. | 2002 | — |
| −3 | K043382 | TMS Full Advantage Full Face Mask, Models TMS-2820, TMS-2830, TMS-2840 | Tiara Medical Systems, Inc. | 2005 | — |
| −2 | K060273 | Sleepnet Mojo Full Face Mask -Small, Model NO. 53835, Medium ,Model… | Sleepnet Corporation | 2006 | — |
| −1 | K120463 | Mojo, Veraseal | Sleepnet Corporation | 2012 | Class I |
| 0 (this device) | K241830 | Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face… | Sleepnet Corporation | 2024 | — |
| +1 | K251920 | Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B… | Dcstar, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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.
1 device in this family has 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 |
|---|---|---|---|
| * | K120463 | Mojo, VerasealSummary page 5…ulation Number: 21CFR 868.5905 Regulation Code: Non-continuous ventilator (IPPB) Product Code: BZD Predicate Device: K120463 – Mojo Full Face Mask and Veraseal Full Face Mask Regulation Number: 21CFR 868.5905 Regulation Code: Non-… | 2012 |
| † | K190254 | Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251920 | Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face… | 2026 | 0 |
Has anything in its family been recalled? (1 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.
- K120463Mojo, VerasealSleepnet Corporation · 2012 · Direct predicate · ◆ 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 6.0 years on median.
- 1 of the 22 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K251920 (Dcstar, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K120463.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Mojo Full Face Vented Mask, Veraseal 2 Full Face Vented Mask, Innova Full Face Vented Mask and Ascend Full Face Vented Mask are intended to be used with positive airway pressure devices, such as CPAP or bilevel, operating at or above 3 cm H2O. The masks are to be used on adult patients (>30kg) for whom positive airway pressure therapy has been prescribed. Mojo is intended for Single patient, multi-use in the home or hospital/institutional…
Read the full statement (122 words)
The Sleepnet Mojo Full Face Vented Mask, Veraseal 2 Full Face Vented Mask, Innova Full Face Vented Mask and
Ascend Full Face Vented Mask are intended to be used with positive airway pressure devices, such as CPAP or bilevel,
operating at or above 3 cm H2O. The masks are to be used on adult patients (>30kg) for whom positive airway pressure
therapy has been prescribed.
Mojo is intended for Single patient, multi-use in the home or hospital/institutional environment.
Veraseal 2 is intended for Short Term Single Patient use (maximum of 7 days) in the hospital/institutional environment.
Innova is intended for Single patient, multi-use in the home or hospital/institutional environment.
Ascend is intended for Single patient, multi-use in the home or hospital/institutional environment.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K241830 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241830: Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241830
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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