510(k) · Cleared
ClearedLaimad
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Steven Lamberg, D.D.S · LRK Device, Anti-Snoring
Cleared on Dec 14, 2006 as substantially equivalent to K973038 (Distar, Inc., 1997) and 2 other predicates after a 126-day review. Its family tree reaches back 2 generations to 2001. 2 later devices descend from it.
- Decided
- Dec 14, 2006
- Review
- 126 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K011560 (2001). 3 ancestors in all, the oldest K973038 (1997). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK011560 Trubyte Denture Base Resin SystemDentsply Intl. · 2001
- 1 generation backK032892 Modification to Trubyte Denture Base Resin SystemDentsply Intl. · 2003
- This deviceK062333 LaimadSteven Lamberg, D.D.S · 2006
- Descendant · cites it directly · 0 of its ownK101155 Auradorm (Neuromuscular Sleep)Sleepwright · 2011
- Descendant · cites it directly · 0 of its ownK101709 Lambergsleepwell- Smartrusion (LSW-S)Steven B. Lamberg, Dds · 2010
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011560 | Trubyte Denture Base Resin System | Dentsply Intl. | 2001 | — |
| −1 | K032892 | Modification to Trubyte Denture Base Resin System | Dentsply Intl. | 2003 | — |
| 0 (this device) | K062333 | Laimad | Steven Lamberg, D.D.S | 2006 | — |
| +1 | K101155 | Auradorm (Neuromuscular Sleep) | Sleepwright | 2011 | — |
| +1 | K101709 | Lambergsleepwell- Smartrusion (LSW-S) | Steven B. Lamberg, Dds | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 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 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? (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 |
|---|---|---|---|
| * | K973038 | Adjustable TherasnoreSummary page 1…364 Common or Usual Name Mandibular advancement device Classification Name Anti-snoring device (Product code: LRK) Predicate Devices TheraSnore (K973038) Distar, Inc. Hawley retainer (Preamendments) Specialty Appliance Works, Inc. Trubyte Denture Base Resin System, and Modificati… | 1997 |
| * | K011560 | Trubyte Denture Base Resin System | 2001 |
| * | K032892 | Modification to Trubyte Denture Base Resin SystemSummary page 1…reamendments) Specialty Appliance Works, Inc. Trubyte Denture Base Resin System, and Modification to Trubyte Denture Base Resin System Dentsply International (KOl 1560, K032892) -0284651000001 -MC 2402861 vl Kevin Mulry, D.D.S. December 7, 2006 Page 10 Intended Use / Ind… | 2003 |
| * | — | Hawley retainer Named without a submission number |
What descends from it? (2)
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?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K101155 (Sleepwright, 2011) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K973038.
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 Lamberg Sleep Well device is intended to reduce night time snoring in adults 18 years of age or older in a home or sleep laboratory environment. The device must be prescribed by a dentist or physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062333 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062333: Laimad.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062333
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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