510(k) · Cleared
ClearedMyoaligner Appliance
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Myohealth Technologies, LLC · MQC Mouthguard, Prescription
Cleared on Feb 2, 2024 as substantially equivalent to K123161 (Smartguard, Inc., 2013) and 2 other predicates after a 339-day review. Its family tree reaches back 8 generations to 1989.
- Decided
- Feb 2, 2024
- Review
- 339 days
- Class
- Class U
- Product code
- MQC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K882303 (1989). 32 ancestors in all, the oldest K880956 (1988). No later device cites it as a predicate yet.
- Root · 8 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 7 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 6 generations backK042161 Anti-Snoring/Sleep Apnea DeviceRj & VK Bird Pty, Ltd. · 2004
- 5 generations backK050592 Somnomed Mas RxaSomnomed, Ltd. · 2005
- 4 generations backK113201 Narval CCResmed Sas · 2011
- 3 generations backK143244 The Panthera Anti-Snoring DevicePanthera Dental, Inc. · 2014
- 2 generations backK203596 Panthera Occlusal AppliancePanthera Dental, Inc. · 2021
- 1 generation backK230495 Serena Sleep Night GuardMeris Investment Group · 2023
- This deviceK230548 Myoaligner ApplianceMyohealth Technologies, LLC · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −7 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −6 | K042161 | Anti-Snoring/Sleep Apnea Device | Rj & VK Bird Pty, Ltd. | 2004 | — |
| −5 | K050592 | Somnomed Mas Rxa | Somnomed, Ltd. | 2005 | — |
| −4 | K113201 | Narval CC | Resmed Sas | 2011 | — |
| −3 | K143244 | The Panthera Anti-Snoring Device | Panthera Dental, Inc. | 2014 | — |
| −2 | K203596 | Panthera Occlusal Appliance | Panthera Dental, Inc. | 2021 | — |
| −1 | K230495 | Serena Sleep Night Guard | Meris Investment Group | 2023 | — |
| 0 (this device) | K230548 | Myoaligner Appliance | Myohealth Technologies, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 3 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 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 MQC? 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 MQC device
- #1 K203000 KeyPrint KeySplint Hardscore 15.3 · 5 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 |
|---|---|---|---|
| * | K123161 | Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original, Smartguard…Summary page 5…d Product Code MQC Subsequent Product OCO Code Primary Predicate SmartGuard Night Guard, Original, Night Guard Original and Elite (K123161) Device Predicate Devices Somnobrux Splints including Michigan, ComnBrux B, Gelb and Tanner… | 2013 |
| * | K102909 | Somnobrux SplintsSummary page 5…t Guard Original and Elite (K123161) Device Predicate Devices Somnobrux Splints including Michigan, ComnBrux B, Gelb and Tanner (K102909), Serena Sleep Night Guard (K230495) Reference Devices NTI-TSS (K010876) and The POD (K182820) for comparison in perfo… | 2011 |
| * | K230495 | Serena Sleep Night Guard Cleared while this submission was under review Summary page 5…Device Predicate Devices Somnobrux Splints including Michigan, ComnBrux B, Gelb and Tanner (K102909), Serena Sleep Night Guard (K230495) Reference Devices NTI-TSS (K010876) and The POD (K182820) for comparison in performance… | 2023 |
| † | K010876 | Nti Tension Suppression System | 2001 |
| † | K182820 | The POD | 2019 |
| † | K201683 | PMMA Block | 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 35 years and passes through 8 companies; a new generation was cleared every 6.3 years on median.
- None of the 32 ancestors has a recall.
- 2 other devices also cite its predicate K123161.
How does its category compare?
All MQC devicesMQC Mouthguard, Prescription: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · MQC
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQC
185in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQC
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQC
7in 2025
MAUDE reports naming product code MQC, 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 | 4 | 79 | 0 | 9 |
| 2008 | 0 | — | 0 | 6 |
| 2009 | 2 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 5 |
| 2011 | 4 | 194 | 0 | 2 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 6 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 3 | 234 | 0 | 5 |
| 2016 | 0 | — | 0 | 9 |
| 2017 | 2 | — | 0 | 7 |
| 2018 | 0 | — | 0 | 71 |
| 2019 | 5 | 286 | 0 | 62 |
| 2020 | 4 | 204 | 0 | 46 |
| 2021 | 7 | 158 | 0 | 111 |
| 2022 | 5 | 120 | 0 | 137 |
| 2023 | 6 | 230 | 1 | 62 |
| 2024 | 8 | 249 | 0 | 8 |
| 2025 | 4 | 185 | 0 | 7 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
For protection against teeth grinding, bruxism, and jaw clenching; protection of restorations from injury due to bruxism or clenching; relief of bruxism related headaches, migraines and pain; short-term relief from muscle spasm due to occlusal interference; prevention of chronic tension and temporal mandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth by the temporalis muscles; and temporary treatment of temporal mandibular disorder (TMD) along with the relief of associated headaches and pains in adults 18 years of age or older.
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/K230548 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230548: Myoaligner Appliance.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230548
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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