510(k) · Cleared
ClearedMyosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Myofunctional Research Co. · LRK Device, Anti-Snoring
Cleared on Mar 2, 2026 as substantially equivalent to K132506 (Michael D Williams Dds PA, 2014) and 4 other predicates after a 202-day review. Its family tree reaches back 9 generations to 1989. 1 later device descends from it.
- Decided
- Mar 2, 2026
- Review
- 202 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K882303 (1989). 43 ancestors in all, the oldest K880956 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 5 generations between
- 3 generations backK091035 Full Breath Sleep Appliance Lower (FBSL)Bryan Keropian Dds · 2009
- 2 generations backK111680 DR. Greensburg's HybridAlways More Marketing, Inc. · 2011
- 1 generation backK182312 Zyppah Anti-Snoring DeviceAlways More Marketing · 2019
- This deviceK252531 Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)Myofunctional Research Co. · 2026
- Descendant · cites it directly · 0 of its ownK261912 SnØreNegatØrDnB Innovations, LLC · 2026
Show all 9 generations
- Root · 9 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 8 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 7 generations backK972061 TOAW. Keith Thornton, D.D.S. · 1997
- 6 generations backK022891 The Breathe EZ Anti-Snoring DeviceD&S Redhage · 2003
- 5 generations backK052862 Full Breath Sleep Appliance - AB (Anterior Bite)Bryan Keropian Dds · 2005
- 4 generations backK061228 Full Breath Sleep Appliance with Posterior Tongue DepressorBryan Keropian Dds · 2006
- 3 generations backK091035 Full Breath Sleep Appliance Lower (FBSL)Bryan Keropian Dds · 2009
- 2 generations backK111680 DR. Greensburg's HybridAlways More Marketing, Inc. · 2011
- 1 generation backK182312 Zyppah Anti-Snoring DeviceAlways More Marketing · 2019
- This deviceK252531 Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)Myofunctional Research Co. · 2026
Most influential descendants
Showing 1 of 1 · See all- K261912SnØreNegatØrDnB Innovations, LLC · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −8 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −7 | K972061 | TOA | W. Keith Thornton, D.D.S. | 1997 | — |
| −6 | K022891 | The Breathe EZ Anti-Snoring Device | D&S Redhage | 2003 | — |
| −5 | K052862 | Full Breath Sleep Appliance - AB (Anterior Bite) | Bryan Keropian Dds | 2005 | — |
| −4 | K061228 | Full Breath Sleep Appliance with Posterior Tongue Depressor | Bryan Keropian Dds | 2006 | — |
| −3 | K091035 | Full Breath Sleep Appliance Lower (FBSL) | Bryan Keropian Dds | 2009 | — |
| −2 | K111680 | DR. Greensburg's Hybrid | Always More Marketing, Inc. | 2011 | — |
| −1 | K182312 | Zyppah Anti-Snoring Device | Always More Marketing | 2019 | — |
| 0 (this device) | K252531 | Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) | Myofunctional Research Co. | 2026 | — |
| +1 | K261912 | SnØreNegatØr | DnB Innovations, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 K253845 Anti Snoring Mouthpiece (L08-BP, L08-PT…score 15.5 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K132506 | Sleeptight Mouthpiece, Sleeppro, Quietnite, Altitude Mouthpiece, Sleep EasySummary page 5…5570 Product Code(s) LRK, LQZ I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K132506, K191618 | | SleepTight Mouthpiece (STM) LRK K111680, K182312 | | Zyppah LRK K231663 AVEOtsd LRK Device Description Summary 21 CF… | 2014 |
| * | K191618 | SleepTight Mouthpiece STZSummary page 5…uct Code(s) LRK, LQZ I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K132506, K191618 | | SleepTight Mouthpiece (STM) LRK K111680, K182312 | | Zyppah LRK K231663 AVEOtsd LRK Device Description Summary 21 CFR 807.92(… | 2019 |
| * | K111680 | DR. Greensburg's HybridSummary page 5…dicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K132506, K191618 | | SleepTight Mouthpiece (STM) LRK K111680, K182312 | | Zyppah LRK K231663 AVEOtsd LRK Device Description Summary 21 CFR 807.92(a)(4) The Myosa and Myosa for Snorers appli… | 2011 |
| * | K182312 | Zyppah Anti-Snoring DeviceSummary page 5…vices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K132506, K191618 | | SleepTight Mouthpiece (STM) LRK K111680, K182312 | | Zyppah LRK K231663 AVEOtsd LRK Device Description Summary 21 CFR 807.92(a)(4) The Myosa and Myosa for Snorers appliances ope… | 2019 |
| * | K231663 | The AVEOtsd (Tongue Stabilizing Device) MouthpieceSummary page 5…3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K132506, K191618 | | SleepTight Mouthpiece (STM) LRK K111680, K182312 | | Zyppah LRK K231663 AVEOtsd LRK Device Description Summary 21 CFR 807.92(a)(4) The Myosa and Myosa for Snorers appliances open the airway, control o… | 2023 |
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 |
|---|---|---|---|
| K261912 | SnØreNegatØr | 2026 | 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 37 years and passes through 8 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 43 ancestors has a recall of any class.
- Of its descendants, K261912 (DnB Innovations, LLC, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K132506.
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?
Rx: The Myosa (S1H, S1, S1M, S2, S2M and S3) appliances are intended to treat snoring and/or mild to
moderate obstructive sleep apnea in adults at least 18 years old.
OTC: The Myosa for Snorers (S1, S1M and S2) are intended to treat snoring in adults at least 18 years old.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K252531 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252531: Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252531
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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