510(k) · Cleared
ClearedTMJ Relax
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Moonwalker Innovations, Inc. · OCO Mouthguard, Migraine/Tension Headache
Cleared on Jun 24, 2021 as substantially equivalent to K010876 (Nti-Tss, Inc., 2001) after a 296-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Jun 24, 2021
- Review
- 296 days
- Class
- Class U
- Product code
- OCO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010876 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK010876 Nti Tension Suppression SystemNti-Tss, Inc. · 2001
- This deviceK202523 TMJ RelaxMoonwalker Innovations, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010876 | Nti Tension Suppression System | Nti-Tss, Inc. | 2001 | — |
| 0 (this device) | K202523 | TMJ Relax | Moonwalker Innovations, Inc. | 2021 | — |
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 OCO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K010876 | Nti Tension Suppression SystemSummary page 4…e Class: Unclassified Device Use: RX Classification Panel: Dental 5. Legally Marketed Predicate Device(s) Primary Predicate: NTI-TSS NTI Tension Suppression System (#K010876) Reference Device: The Luco Hybrid OSA Appliance (#K160477) 6. Device Description TMJ RelaxTM is durable medical equipment i… | 2001 |
| † | K160477 | The Luco Hybrid OSA Appliance | 2016 |
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?
- Its one ancestor has no recall.
- 5 other devices also cite its predicate K010876.
How does its category compare?
All OCO devicesOCO Mouthguard, Migraine/Tension Headache: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · OCO
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · OCO
Too few OCO 510(k)s in any year since 2007 to give a median.
Recalls per year · OCO
No recall names OCO since 2007.
Adverse event reports per year · OCO
5in 2023
MAUDE reports naming product code OCO, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
A device to be used in the prophylactic treatment of medically diagnosed migraine pain as well as migraine associated tension-type headaches, by reducing their signs and symptoms through reduction of trigeminally innervated muscular activity, and;
For the prevention of bruxism and TMJ syndrome through reduction of trigeminally innervated muscular activity
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/K202523 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202523: TMJ Relax.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202523
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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