510(k) · Cleared
ClearedGrindcare
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medotech A/S · HCC Device, Biofeedback
Cleared on Mar 3, 2010 as substantially equivalent to K030869 (S.L.P., Ltd., 2004) and 2 other predicates after a 183-day review. Its family tree reaches back 2 generations to 1984. 2 later devices descend from it.
- Decided
- Mar 3, 2010
- Review
- 183 days
- Class
- Class II
- Product code
- HCC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K842223 (1984). 8 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK842223 J4 Myo-MonitorMyo-Tronics Research, Inc. · 1984
- 1 generation backK031998 Model J-5 Mvo-MonitorMyotronics-Noromed, Inc. · 2003
- This deviceK092675 GrindcareMedotech A/S · 2010
- Descendant · cites it directly · 0 of its ownK163448 GrindCare SystemSunstar Suisse S.A. · 2017
- Descendant · cites it directly · 0 of its ownK113677 Grindcare MeasureMedotech A/S · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K842223 | J4 Myo-Monitor | Myo-Tronics Research, Inc. | 1984 | — |
| −1 | K031998 | Model J-5 Mvo-Monitor | Myotronics-Noromed, Inc. | 2003 | — |
| 0 (this device) | K092675 | Grindcare | Medotech A/S | 2010 | — |
| +1 | K163448 | GrindCare System | Sunstar Suisse S.A. | 2017 | — |
| +1 | K113677 | Grindcare Measure | Medotech A/S | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2017 | 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 HCC? 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 HCC device
- #1 K233580 A Breathing System (ABS)score 8.1 · 2 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K030869 | BitestripSummary page 3…at is intended to relax the muscle and inhibit the bruxing event. GRINDCARE is substantially equivalent to the following predicate devices: * SLP, Inc Bitestrip (K030869) * Myotronics Noromed Model J-5 Myomonitor (K03 1998) * Cole and Associates Mentamnove (K040849)… | 2004 |
| * | K031998 | Model J-5 Mvo-MonitorSummary page 3…event. GRINDCARE is substantially equivalent to the following predicate devices: * SLP, Inc Bitestrip (K030869) * Myotronics Noromed Model J-5 Myomonitor (K03 1998) * Cole and Associates Mentamnove (K040849)… | 2003 |
| * | K040849 | MentamoveSummary page 3…the following predicate devices: * SLP, Inc Bitestrip (K030869) * Myotronics Noromed Model J-5 Myomonitor (K03 1998) * Cole and Associates Mentamnove (K040849) Page 15 DEPARTMENT OF HEA… | 2004 |
What descends from it? (2)
2 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 26 years and passes through 3 companies; a new generation was cleared every 18.7 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K163448 (Sunstar Suisse S.A., 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K030869.
How does its category compare?
All HCC devicesHCC Device, Biofeedback: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · HCC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HCC
Too few HCC 510(k)s in any year since 2007 to give a median.
Recalls per year · HCC
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HCC
5in 2024
MAUDE reports naming product code HCC, 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 | 2 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 0 | — | 1 | 2 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 2 | — | 1 | 0 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The GRINDCARE device is indicated to aid in the evaluation and management of nocturnal bruxism by reducing the temporalis muscle EMG activity during sleep.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092675 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092675: Grindcare.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092675
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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