510(k) · Cleared
ClearedGrindcare Measure
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medotech A/S · KZM Device, Muscle Monitoring
Cleared on Apr 5, 2012 as substantially equivalent to K092675 (Medotech A/S, 2010) and 1 other predicate after a 113-day review. Its family tree reaches back 3 generations to 1984.
- Decided
- Apr 5, 2012
- Review
- 113 days
- Class
- Class II
- Product code
- KZM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K842223 (1984). 9 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K842223 | J4 Myo-Monitor | Myo-Tronics Research, Inc. | 1984 | — |
| −2 | K031998 | Model J-5 Mvo-Monitor | Myotronics-Noromed, Inc. | 2003 | — |
| −1 | K092675 | Grindcare | Medotech A/S | 2010 | — |
| 0 (this device) | 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 |
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 KZM? 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? (2)
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 |
|---|---|---|---|
| * | K092675 | GrindcareSummary page 1…electromyography, Class HI Panel: Dental Product Code: KZM: Dental Muscle Monitoring Device Predicate Devices: GRINDCARE - K092675 SLP, Inc Bitestrip - K(030869 Indication for Use: The GRINDCARE MEASURE device is indicated to aid i… | 2010 |
| * | K030869 | BitestripSummary page 1…tal Product Code: KZM: Dental Muscle Monitoring Device Predicate Devices: GRINDCARE - K092675 SLP, Inc Bitestrip - K(030869 Indication for Use: The GRINDCARE MEASURE device is indicated to aid in the evaluation of nocturnal bruxism by measuring the tem… | 2004 |
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 28 years and passes through 3 companies; a new generation was cleared every 6.6 years on median.
- None of the 9 ancestors has a recall.
- 1 other device also cites its predicate K092675.
How does its category compare?
All KZM devicesKZM Device, Muscle Monitoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · KZM
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · KZM
Too few KZM 510(k)s in any year since 2007 to give a median.
Recalls per year · KZM
No recall names KZM since 2007.
Adverse event reports per year · KZM
No MAUDE report names KZM since 2007.
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 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The GRINDCARE MEASURE device is indicated to aid in the evaluation of nocturnal bruxism by measuring the temporalis muscle EMG activity during sleep.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113677 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113677: Grindcare Measure.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113677
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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