510(k) · Cleared
ClearedAuradorm (Neuromuscular Sleep)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sleepwright · LRK Device, Anti-Snoring
Cleared on May 12, 2011 as substantially equivalent to K062333 (Steven Lamberg, D.D.S, 2006) and 2 other predicates after a 381-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- May 12, 2011
- Review
- 381 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K011560 (2001). 11 ancestors in all, the oldest K882303 (1989). No later device cites it as a predicate yet.
- Root · 3 generations backK011560 Trubyte Denture Base Resin SystemDentsply Intl. · 2001
- 2 generations backK032892 Modification to Trubyte Denture Base Resin SystemDentsply Intl. · 2003
- 1 generation backK062333 LaimadSteven Lamberg, D.D.S · 2006
- This deviceK101155 Auradorm (Neuromuscular Sleep)Sleepwright · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011560 | Trubyte Denture Base Resin System | Dentsply Intl. | 2001 | — |
| −2 | K032892 | Modification to Trubyte Denture Base Resin System | Dentsply Intl. | 2003 | — |
| −1 | K062333 | Laimad | Steven Lamberg, D.D.S | 2006 | — |
| 0 (this device) | K101155 | Auradorm (Neuromuscular Sleep) | Sleepwright | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1997 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K062333 | LaimadSummary page 1…Product Code: LRK Classification: Class 11 510K # K101 155/ Devices far Which Substantial Equivalence is Claimed: Lamberg Sleep Well Device K062333 Snore Guard K103004 Acrylic Herbst Appliance K083209 Device Description: The Auradorm Sleep Applian… | 2006 |
| * | K103004 | Snore Guard Cleared while this submission was under review Summary page 1…assification: Class 11 510K # K101 155/ Devices far Which Substantial Equivalence is Claimed: Lamberg Sleep Well Device K062333 Snore Guard K103004 Acrylic Herbst Appliance K083209 Device Description: The Auradorm Sleep Appliance is a one piece oral appl… | 2011 |
| * | K083209 | Acrylic Herbst Splint ApplianceSummary page 1…1 155/ Devices far Which Substantial Equivalence is Claimed: Lamberg Sleep Well Device K062333 Snore Guard K103004 Acrylic Herbst Appliance K083209 Device Description: The Auradorm Sleep Appliance is a one piece oral appliance used for reducing snoring and… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 10 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- None of the 11 ancestors has a recall.
- 1 other device also cites its predicate K062333.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 Auradorm sleep appliance is a dentist prescribed mandibular repositioning device worn during sleep to reduce the incidence of snoring and reduce the effects of mild to moderate obstructive sleep apnea for patients 18 years or older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101155 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101155: Auradorm (Neuromuscular Sleep).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101155
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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