510(k) · Cleared
ClearedDormiva Anti-Snoring Mouth Guard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Koncept Innovators, Inc. · LRK Device, Anti-Snoring
Cleared on May 14, 2026 as substantially equivalent to K201484 (Koncept Innovators, LLC, 2020) after a 37-day review. Its family tree reaches back 7 generations to 2007.
- Decided
- May 14, 2026
- Review
- 37 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K071404 (2007). 12 ancestors in all, the oldest K882303 (1989). No later device cites it as a predicate yet.
- Root · 7 generations backK071404 Sleep Right - Select, Low Profile and AdvancePower Products, Inc.-Splintek · 2007
- 6 generations backK100545 SleeprightPower Products, Inc.-Splintek · 2010
- 5 generations backK103004 Snore GuardRanir, LLC · 2011
- 4 generations backK112205 Snorerx 9.0Consumer Health Products, Inc. · 2011
- 3 generations backK153200 SnoreRxApnea Sciences Corporation · 2016
- 2 generations backK170825 SnoreRxApnea Sciences Corporation · 2017
- 1 generation backK201484 Somnos Anti-Snoring Mouth GuardKoncept Innovators, LLC · 2020
- This deviceK261134 Dormiva Anti-Snoring Mouth GuardKoncept Innovators, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K071404 | Sleep Right - Select, Low Profile and Advance | Power Products, Inc.-Splintek | 2007 | — |
| −6 | K100545 | Sleepright | Power Products, Inc.-Splintek | 2010 | — |
| −5 | K103004 | Snore Guard | Ranir, LLC | 2011 | — |
| −4 | K112205 | Snorerx 9.0 | Consumer Health Products, Inc. | 2011 | — |
| −3 | K153200 | SnoreRx | Apnea Sciences Corporation | 2016 | — |
| −2 | K170825 | SnoreRx | Apnea Sciences Corporation | 2017 | — |
| −1 | K201484 | Somnos Anti-Snoring Mouth Guard | Koncept Innovators, LLC | 2020 | — |
| 0 (this device) | K261134 | Dormiva Anti-Snoring Mouth Guard | Koncept Innovators, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1995 | 2 | 0 |
| 1998 | 1 | 0 |
| 2010 | 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? (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 |
|---|---|---|---|
| * | K201484 | Somnos Anti-Snoring Mouth GuardSummary page 5…Product Code: LRK Review Panel: Dental Legally Marketed Predicate Device Primary Predicate Device: SOMNOS ANTI-SNORING MOUTH GUARD, K201484 This legally marketed device predicate has not been subject to a design-related recall. Koncept Innovators, LLC.… | 2020 |
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 19 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
- None of the 12 ancestors has a recall.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
DORMIVA ANTI-SNORING MOUTH GUARD is an over-the-counter mouth guard intended for use in adult persons 18 years of age or older as an aid for the reduction of snoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261134 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261134: Dormiva Anti-Snoring Mouth Guard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261134
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026