510(k) · Cleared
ClearedMigra Tab, Quicksplint Migraine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Migratherapy, LLC · MQC Mouthguard, Prescription
Cleared on Nov 22, 2011 as substantially equivalent to K040315 (Mci-Myohealth Systems, 2004) and 1 other predicate after a 218-day review. Its family tree reaches back 2 generations to 1989. 7 later devices descend from it.
- Decided
- Nov 22, 2011
- Review
- 218 days
- Class
- Class U
- Product code
- MQC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K882303 (1989). 5 ancestors in all. 7 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 1 generation backK014079 DR. Hays Bite GuardInventive Resources, Inc. · 2002
- This deviceK111066 Migra Tab, Quicksplint MigraineMigratherapy, LLC · 2011
- Descendant · cites it directly · 4 of its ownK170985 Urbanek DeviceTmj Services, LLC · 2017
- Descendant · 2 generations on · 3 of its ownK182820 The PODAdvanced Facialdontics, LLC · 2019
- Descendant · 3 generations on · 2 of its ownK203596 Panthera Occlusal AppliancePanthera Dental, Inc. · 2021
- Descendant · 4 generations on · 1 of its ownK230495 Serena Sleep Night GuardMeris Investment Group · 2023
- Descendant · 5 generations on · 0 of its ownK230548 Myoaligner ApplianceMyohealth Technologies, LLC · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K170985Urbanek DeviceTmj Services, LLC · 2017 · cites it directly4descendants
- K182820The PODAdvanced Facialdontics, LLC · 2019 · 2 generations on3descendants
- K203596Panthera Occlusal AppliancePanthera Dental, Inc. · 2021 · 3 generations on2descendants
- K230495Serena Sleep Night GuardMeris Investment Group · 2023 · 4 generations on1descendant
- K230548Myoaligner ApplianceMyohealth Technologies, LLC · 2024 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −1 | K014079 | DR. Hays Bite Guard | Inventive Resources, Inc. | 2002 | — |
| 0 (this device) | K111066 | Migra Tab, Quicksplint Migraine | Migratherapy, LLC | 2011 | — |
| +1 | K170985 | Urbanek Device | Tmj Services, LLC | 2017 | — |
| +2 | K182820 | The POD | Advanced Facialdontics, LLC | 2019 | — |
| +3 | K203596 | Panthera Occlusal Appliance | Panthera Dental, Inc. | 2021 | — |
| +4 | K230495 | Serena Sleep Night Guard | Meris Investment Group | 2023 | — |
| +5 | K230548 | Myoaligner Appliance | Myohealth Technologies, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 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 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 |
|---|---|---|---|
| * | K040315 | Myohealth Clenching InhibitorSummary page 3…ng bite plate (pre- K014079 inhibitor 1972 device) K040315 __________ Indications Protection of teeth Same Same… | 2004 |
| * | K014079 | DR. Hays Bite GuardSummary page 3…uickSplint Myohealth custom fabricated Guard K11066 Clenching bite plate (pre- K014079 inhibitor 1972 device) K040315… | 2002 |
| * | — | Custom fabricated full occlusal coverage bite plate (pre-1972 device) Named without a submission number |
What descends from it? (7)
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 22 years and passes through 3 companies; a new generation was cleared every 12.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K170985 (Tmj Services, LLC, 2017) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K040315.
How does its category compare?
All MQC devicesMQC Mouthguard, Prescription: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
Protection of teeth and restorations from injury due to bruxisni or clenching.
Relief of bruxism related headaches and pains.
Treatment of Temporal Mandibular Disorder (TMD) along with the relief of associated headaches and pains.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111066 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111066: Migra Tab, Quicksplint Migraine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111066
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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