510(k) · Cleared
ClearedTiara Medical Systems Advantage II Nasal Mask, Models TMS-2520 and TMS-2530
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tiara Medical Systems, Inc. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Mar 3, 2004 as substantially equivalent to K012207 (Tiara Medical Systems, Inc., 2001) and 1 other predicate after a 254-day review. Its family tree reaches back 1 generation to 1998. 8 of the 26 devices in its family, counting itself, have a Class I recall. 23 later devices descend from it.
- Decided
- Mar 3, 2004
- Review
- 254 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K980721 (1998). 2 ancestors in all. 23 later devices descend from it, 2 citing it directly. 8 of the 26 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK980721 Sullivan AutosetResmed, Ltd. · 1998
- This deviceK031935 Tiara Medical Systems Advantage II Nasal Mask, Models TMS-2520 and…Tiara Medical Systems, Inc. · 2004
- Descendant · cites it directly · 21 of its ownK043382 TMS Full Advantage Full Face Mask, Models TMS-2820, TMS-2830, TMS-2840Tiara Medical Systems, Inc. · 2005
- Descendant · 2 generations on · 20 of its ownK060273 Sleepnet Mojo Full Face Mask -Small, Model NO. 53835, Medium ,Model…Sleepnet Corporation · 2006
- Descendant · 3 generations on · 7 of its ownK132887 Airfit N10Resmed, Ltd. · 2013 · Recalled (Class I)
- Descendant · 4 generations on · 6 of its ownK153673 AirFit N20Resmed, Ltd. · 2016
- Descendant · 3 generations on · 6 of its ownK063806 Sleepnet Mojo -NV Full Face Mask, Non-VentedSleepnet Corporation · 2007 · Recalled (Class I)
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 23 · See all- K043382TMS Full Advantage Full Face Mask, Models TMS-2820, TMS-2830, TMS-2840Tiara Medical Systems, Inc. · 2005 · cites it directly21descendants
- K060273Sleepnet Mojo Full Face Mask -Small, Model NO. 53835, Medium ,Model NO.53836,Large,Model…Sleepnet Corporation · 2006 · 2 generations on20descendants
- K132887Airfit N10Resmed, Ltd. · 2013 · 3 generations on7descendants
- K153673AirFit N20Resmed, Ltd. · 2016 · 4 generations on6descendants
- K063806Sleepnet Mojo -NV Full Face Mask, Non-VentedSleepnet Corporation · 2007 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K980721 | Sullivan Autoset | Resmed, Ltd. | 1998 | — |
| 0 (this device) | K031935 | Tiara Medical Systems Advantage II Nasal Mask, Models TMS-2520 and TMS-2530 | Tiara Medical Systems, Inc. | 2004 | — |
| +1 | 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 | — |
| +3 | K132887 | Airfit N10 | Resmed, Ltd. | 2013 | Class I |
| +4 | K153673 | AirFit N20 | Resmed, Ltd. | 2016 | — |
| +3 | K063806 | Sleepnet Mojo -NV Full Face Mask, Non-Vented | Sleepnet Corporation | 2007 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 1 |
| 2008 | 1 | 1 |
| 2010 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K012207 | Advantage Nasal Mask, Small, Advantage Nasal Mask. Regular, Models TMS-2520, TMS 2530Summary page 1…Nasal Mask Classification Name: Ventilator, Noncontinuous (Respirator), 73BZD Predicate devices: TMS Advantage Series, K012207, Sullivan AutoSet Nasal CPAP System (includes ResMed Protoge),… | 2001 |
| * | K980721 | Sullivan AutosetSummary page 1…TMS Advantage Series, K012207, Sullivan AutoSet Nasal CPAP System (includes ResMed Protoge), K980721 Reason for submission: Modification to design, labeling Device Description: The Tiara Medical Systems.Advantage j… | 1998 |
What descends from it? (23)
See all 232 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 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K063806Sleepnet Mojo -NV Full Face Mask, Non-VentedSleepnet Corporation · 2007 · 3 generations on · ◆ 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 · 3 generations on · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls
- K120463Mojo, VerasealSleepnet Corporation · 2012 · 3 generations on · ◆ 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 · 4 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 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
- K161978AirFit N20Resmed, Ltd. · 2016 · 5 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K171212AirFit N20Resmed, Ltd. · 2017 · 6 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?
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 Tiara Medical Systems Advantage II Nasal Mask is intended to be used with continuous positive airway pressure devices (CPAP), operating at or above 3 cmH20 for the treatment of obstructive sleep apnea. The mask is intended for single patient use and can be used in the home or in a hospital/institutional environment. The mask is to be used on adult patients (>30Kg) for whom continuous positive airway pressure has been prescribed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031935 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031935: Tiara Medical Systems Advantage II Nasal Mask, Models TMS-2520 and TMS-2530.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031935
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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