510(k) · Cleared
ClearedTMS Snapp Soft Nasal Accessory for Positive Pressure, Models TMS-3020, TMS-3030 & TMS-3040
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 Jun 24, 2004 as substantially equivalent to K012207 (Tiara Medical Systems, Inc., 2001) and 3 other predicates after a 177-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it.
- Decided
- Jun 24, 2004
- Review
- 177 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K945938 (1996). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK945938 Respironics Monarch Mini MaskRespironics, Inc. · 1996
- 1 generation backK990659 Nasal AireBreathing Technologies Corp. · 1999
- This deviceK034053 TMS Snapp Soft Nasal Accessory for Positive Pressure, Models…Tiara Medical Systems, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK051583 Tiara Snapp X Soft Nasal Accessory for Positive Pressure, Models…Tiara Medical Systems, Inc. · 2005
Most influential descendants
Showing 1 of 1 · See all- K051583Tiara Snapp X Soft Nasal Accessory for Positive Pressure, Models TMS-3020, TMS-3030…Tiara Medical Systems, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945938 | Respironics Monarch Mini Mask | Respironics, Inc. | 1996 | — |
| −1 | K990659 | Nasal Aire | Breathing Technologies Corp. | 1999 | — |
| 0 (this device) | K034053 | TMS Snapp Soft Nasal Accessory for Positive Pressure, Models TMS-3020… | Tiara Medical Systems, Inc. | 2004 | — |
| +1 | K051583 | Tiara Snapp X Soft Nasal Accessory for Positive Pressure, Models TMS-3020… | Tiara Medical Systems, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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? (4)
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: Tiara Medical Systems Advantage Series, K012207, Breathing Technologies Nasal Aire, K990659, Innomned Tec… | 2001 |
| * | K990659 | Nasal AireSummary page 1…rator), 73BZD Predicate devices: Tiara Medical Systems Advantage Series, K012207, Breathing Technologies Nasal Aire, K990659, Innomned Technologies Nasal Aire 11TM K022465, Sensormed… | 1999 |
| * | K022465 | Modification to Nasal-AireSummary page 1…eries, K012207, Breathing Technologies Nasal Aire, K990659, Innomned Technologies Nasal Aire 11TM K022465, Sensormedics Lyra Nasal Mask, K031883, Reason for submission: Not previously ma… | 2003 |
| * | K031883 | Lyra Nasal MaskSummary page 1…Nasal Aire, K990659, Innomned Technologies Nasal Aire 11TM K022465, Sensormedics Lyra Nasal Mask, K031883, Reason for submission: Not previously marketed in the USA Device! Description and Materials: The Tiara Medical Sys… | 2003 |
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 |
|---|---|---|---|
| K051583 | Tiara Snapp X Soft Nasal Accessory for Positive Pressure, Models TMS-3020, TMS-3030… | 2005 | 0 |
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?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 4.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K051583 (Tiara Medical Systems, Inc., 2005) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K012207.
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 SNAPP 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 SNAPP is intended for single patient use and can be used in the home or in a hospital/institutional environment. The SNAPP 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/K034053 · printed Nov 4, 2026
Cite this page
510(k) Report. “K034053: TMS Snapp Soft Nasal Accessory for Positive Pressure, Models TMS-3020, TMS-3030 & TMS-3040.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K034053
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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