510(k) · Cleared
ClearedLyra Nasal Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sensor Medics Corp. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Aug 25, 2003 as substantially equivalent to K022465 (Innomed Technologies, 2003) after a 68-day review. Its family tree reaches back 1 generation to 2003. 3 later devices descend from it.
- Decided
- Aug 25, 2003
- Review
- 68 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K022465 (2003). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK022465 Modification to Nasal-AireInnomed Technologies · 2003
- This deviceK031883 Lyra Nasal MaskSensor Medics Corp. · 2003
- Descendant · cites it directly · 1 of its ownK034053 TMS Snapp Soft Nasal Accessory for Positive Pressure, Models…Tiara Medical Systems, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK061099 Breathx Nasal Pillow and Mask System, Model 011-0003Hoffman Laboratories, LLC · 2006
- Descendant · 2 generations on · 0 of its ownK051583 Tiara Snapp X Soft Nasal Accessory for Positive Pressure, Models…Tiara Medical Systems, Inc. · 2005
Most influential descendants
Showing 3 of 3 · See all- K034053TMS Snapp Soft Nasal Accessory for Positive Pressure, Models TMS-3020, TMS-3030 & TMS-3040Tiara Medical Systems, Inc. · 2004 · cites it directly1descendant
- K061099Breathx Nasal Pillow and Mask System, Model 011-0003Hoffman Laboratories, LLC · 2006 · cites it directly0descendants
- K051583Tiara Snapp X Soft Nasal Accessory for Positive Pressure, Models TMS-3020, TMS-3030…Tiara Medical Systems, Inc. · 2005 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K022465 | Modification to Nasal-Aire | Innomed Technologies | 2003 | — |
| 0 (this device) | K031883 | Lyra Nasal Mask | Sensor Medics Corp. | 2003 | — |
| +1 | K034053 | TMS Snapp Soft Nasal Accessory for Positive Pressure, Models TMS-3020… | Tiara Medical Systems, Inc. | 2004 | — |
| +1 | K061099 | Breathx Nasal Pillow and Mask System, Model 011-0003 | Hoffman Laboratories, LLC | 2006 | — |
| +2 | K051583 | Tiara Snapp X Soft Nasal Accessory for Positive Pressure, Models TMS-3020… | Tiara Medical Systems, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 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.
Planning a device in BZD? 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 |
|---|---|---|---|
| * | K022465 | Modification to Nasal-AireSummary page 2…treating adult patients. Predicate De vice Substantial equivalence is claimed to the lnnomed Technologies’ Nasal-AireTMNasal Mask having 510(k) No. K022465. Summary of Performance Testing There are no known mandatory or voluntary performance standards applicable to this… | 2003 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
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 LyraTM Nasal Mask is intended for use with devices that deliver Continuous Positive Airway Pressure (CPAP) and bi-level positive airway pressure in treating adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031883 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031883: Lyra Nasal Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031883
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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