510(k) · Cleared
ClearedMrna Appliance
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomodeling Solutions, Lls · LRK Device, Anti-Snoring
Cleared on May 8, 2014 as substantially equivalent to K050592 (Somnomed, Ltd., 2005) and 2 other predicates after a 483-day review. Its family tree reaches back 9 generations to 1989. 5 later devices descend from it.
- Decided
- May 8, 2014
- Review
- 483 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K882303 (1989). 17 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 5 generations between
- 3 generations backK061732 TAP-TAirway Management, Inc. · 2006
- 2 generations backK103076 DynaflexDyna Flex · 2011
- 1 generation backK130130 Atg/SM-Osa AppliancesSelane Products, Inc. · 2013
- This deviceK130067 Mrna ApplianceBiomodeling Solutions, Lls · 2014
- Descendant · cites it directly · 2 of its ownK222872 DNA ApplianceVivos Therapeutics, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK230947 C.A.R.E. Appliance (DNA, mRNA, mmRNA)Vivos Therapeutics, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK234089 DNA ApplianceVivos Therapeutics · 2024
- Descendant · cites it directly · 0 of its ownK210203 mmRNA applianceVivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I) · 2021
- Descendant · cites it directly · 0 of its ownK181123 ApnoDent ApplianceApnomed, Inc. · 2018
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 backK030440 Oasys-Oral Airway SystemMark Abramson, D.D.S., Inc. · 2003
- 4 generations backK060388 Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with…Airway Management, Inc. · 2006
- 3 generations backK061732 TAP-TAirway Management, Inc. · 2006
- 2 generations backK103076 DynaflexDyna Flex · 2011
- 1 generation backK130130 Atg/SM-Osa AppliancesSelane Products, Inc. · 2013
- This deviceK130067 Mrna ApplianceBiomodeling Solutions, Lls · 2014
Most influential descendants
Showing 5 of 5 · See all- K222872DNA ApplianceVivos Therapeutics, Inc. · 2022 · cites it directly2descendants
- K230947C.A.R.E. Appliance (DNA, mRNA, mmRNA)Vivos Therapeutics, Inc. · 2023 · 2 generations on1descendant
- K234089DNA ApplianceVivos Therapeutics · 2024 · 3 generations on0descendants
- K210203mmRNA applianceVivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I) · 2021 · cites it directly0descendants
- K181123ApnoDent ApplianceApnomed, Inc. · 2018 · 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 | K030440 | Oasys-Oral Airway System | Mark Abramson, D.D.S., Inc. | 2003 | — |
| −4 | K060388 | Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with Attachment | Airway Management, Inc. | 2006 | — |
| −3 | K061732 | TAP-T | Airway Management, Inc. | 2006 | — |
| −2 | K103076 | Dynaflex | Dyna Flex | 2011 | — |
| −1 | K130130 | Atg/SM-Osa Appliances | Selane Products, Inc. | 2013 | — |
| 0 (this device) | K130067 | Mrna Appliance | Biomodeling Solutions, Lls | 2014 | — |
| +1 | K222872 | DNA Appliance | Vivos Therapeutics, Inc. | 2022 | — |
| +2 | K230947 | C.A.R.E. Appliance (DNA, mRNA, mmRNA) | Vivos Therapeutics, Inc. | 2023 | — |
| +3 | K234089 | DNA Appliance | Vivos Therapeutics | 2024 | — |
| +1 | K210203 | mmRNA appliance | Vivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I) | 2021 | — |
| +1 | K181123 | ApnoDent Appliance | Apnomed, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K050592 | Somnomed Mas RxaSummary page 2…ance in the dental office for patient use at home. Substantial Equivalence to Predicate Devices The mRNA is being compared to the following predicate devices: SomnoMed (K050592), Dynaflex {K103076), and Adjustabie Dorsal (K130130). e Indication for Use: All devices are indicated “to reduce night time sno… | 2005 |
| * | K103076 | DynaflexSummary page 1…ctive Sleep Apnea Device, Jaw-position Device Propose'd Product Code: LRK Predicate Devices: SomnoMed MAS R x A, K0O50592 DynaFlex Anti-Snoring and Sleep Apnea Devices, K103076 Adjustable Dorsal Intraoral Device, K130130 Device Description The mRNA appliance is an intraoral device used for treating snor… | 2011 |
| * | K130130 | Atg/SM-Osa Appliances Cleared while this submission was under review Summary page 1…e Propose'd Product Code: LRK Predicate Devices: SomnoMed MAS R x A, K0O50592 DynaFlex Anti-Snoring and Sleep Apnea Devices, K103076 Adjustable Dorsal Intraoral Device, K130130 Device Description The mRNA appliance is an intraoral device used for treating snoring and mild to moderate sleep apnea, functi… | 2013 |
What descends from it? (5)
3 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 25 years and passes through 9 companies; a new generation was cleared every 2.5 years on median.
- None of the 17 ancestors has a recall.
- Of its descendants, K222872 (Vivos Therapeutics, Inc., 2022) has gone furthest, with 2 descendants of its own.
- 16 other devices also cite its predicate K050592.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
For the treatment of snoring and mild to moderate obstructive sleep apnea in adults.
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/K130067 · printed Nov 5, 2026
Cite this page
510(k) Report. “K130067: Mrna Appliance.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130067
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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