510(k) · Cleared
ClearedAdjustable Therasnore
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Distar, Inc. · LRK Device, Anti-Snoring
Cleared on Nov 12, 1997 after a 90-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Nov 12, 1997
- Review
- 90 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK973038 Adjustable TherasnoreDistar, Inc. · 1997
- Descendant · cites it directly · 2 of its ownK062333 LaimadSteven Lamberg, D.D.S · 2006
- Descendant · cites it directly · 0 of its ownK140663 TherasnoreDistar, LLC · 2014
- Descendant · 2 generations on · 0 of its ownK101155 Auradorm (Neuromuscular Sleep)Sleepwright · 2011
- Descendant · 2 generations on · 0 of its ownK101709 Lambergsleepwell- Smartrusion (LSW-S)Steven B. Lamberg, Dds · 2010
Most influential descendants
Showing 4 of 4 · See all- K062333LaimadSteven Lamberg, D.D.S · 2006 · cites it directly2descendants
- K140663TherasnoreDistar, LLC · 2014 · cites it directly0descendants
- K101155Auradorm (Neuromuscular Sleep)Sleepwright · 2011 · 2 generations on0descendants
- K101709Lambergsleepwell- Smartrusion (LSW-S)Steven B. Lamberg, Dds · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973038 | Adjustable Therasnore | Distar, Inc. | 1997 | — |
| +1 | K062333 | Laimad | Steven Lamberg, D.D.S | 2006 | — |
| +1 | K140663 | Therasnore | Distar, LLC | 2014 | — |
| +2 | K101155 | Auradorm (Neuromuscular Sleep) | Sleepwright | 2011 | — |
| +2 | K101709 | Lambergsleepwell- Smartrusion (LSW-S) | Steven B. Lamberg, Dds | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LRK? 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 LRK device
- #1 K252531 Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for…score 16.3 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
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?
- Of its descendants, K062333 (Steven Lamberg, D.D.S, 2006) has gone furthest, with 2 descendants of its own.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LRK
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LRK
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LRK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LRK
653in 2025
MAUDE reports naming product code LRK, 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 | 1 | — | 0 | 0 |
| 2008 | 3 | 109 | 0 | 1 |
| 2009 | 3 | 88 | 2 | 11 |
| 2010 | 8 | 195 | 0 | 7 |
| 2011 | 10 | 134 | 0 | 69 |
| 2012 | 10 | 142 | 0 | 445 |
| 2013 | 9 | 233 | 0 | 72 |
| 2014 | 11 | 219 | 0 | 49 |
| 2015 | 6 | 117 | 0 | 28 |
| 2016 | 10 | 157 | 0 | 18 |
| 2017 | 7 | 170 | 0 | 32 |
| 2018 | 10 | 200 | 0 | 61 |
| 2019 | 13 | 150 | 0 | 56 |
| 2020 | 5 | 80 | 0 | 24 |
| 2021 | 10 | 126 | 0 | 49 |
| 2022 | 11 | 154 | 0 | 40 |
| 2023 | 5 | 156 | 0 | 50 |
| 2024 | 6 | 254 | 0 | 185 |
| 2025 | 14 | 107 | 1 | 653 |
| 2026 | 10 | 63 | 1 | — |
What is it indicated for?
The Adjustable TheraSnore is a treatment for snoring.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973038 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973038: Adjustable Therasnore.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973038
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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