510(k) · Cleared
ClearedModification to K6-I Diagnostic System, Model K6-I
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Myotronics-Noromed, Inc. · KZM Device, Muscle Monitoring
Cleared on Sep 10, 1999 after a 29-day review. Our reading found no predicate number; beside “510(k)” the summary prints a number our reading could not make out (“15425”). 4 later devices descend from it.
- Decided
- Sep 10, 1999
- Review
- 29 days
- Class
- Class II
- Product code
- KZM
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK992694 Modification to K6-I Diagnostic System, Model K6-IMyotronics-Noromed, Inc. · 1999
- Descendant · cites it directly · 3 of its ownK030869 BitestripS.L.P., Ltd. · 2004
- Descendant · 2 generations on · 2 of its ownK092675 GrindcareMedotech A/S · 2010
- Descendant · 3 generations on · 0 of its ownK163448 GrindCare SystemSunstar Suisse S.A. · 2017
- Descendant · 2 generations on · 0 of its ownK113677 Grindcare MeasureMedotech A/S · 2012
Most influential descendants
Showing 4 of 4 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992694 | Modification to K6-I Diagnostic System, Model K6-I | Myotronics-Noromed, Inc. | 1999 | — |
| +1 | K030869 | Bitestrip | S.L.P., Ltd. | 2004 | — |
| +2 | K092675 | Grindcare | Medotech A/S | 2010 | — |
| +3 | K163448 | GrindCare System | Sunstar Suisse S.A. | 2017 | — |
| +2 | K113677 | Grindcare Measure | Medotech A/S | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2010 | 1 | 0 |
| 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 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? (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 |
|---|---|---|---|
| * | — | ProComp DSP & ProComp Named without a submission number | |
| * | — | Myosystem 1000 Electromyograph Named without a submission number | |
| * | — | I-330 Physiological Monitor Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030869 | Bitestrip | 2004 | 3 |
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?
- Of its descendants, K030869 (S.L.P., Ltd., 2004) has gone furthest, with 3 descendants of its own.
How does its category compare?
All KZM devicesKZM Device, Muscle Monitoring: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
For Jaw Tracking functions of this device: Tracks mandibular movement and position For the diagnosis of functional disorders such as TMJJMPD syndrome, muscle tension, bruxing, and instability of occlusion Identification of mandibular rest position Identification of interocclusal distance and freeway space Monitors the position of the jaw in three dimensions Represents the spatial position of the mandibular incisal edge relative to the skull For…
Read the full statement (177 words)
For Jaw Tracking functions of this device:
Tracks mandibular movement and position
For the diagnosis of functional disorders such as TMJJMPD syndrome, muscle tension, bruxing, and instability of occlusion
Identification of mandibular rest position
Identification of interocclusal distance and freeway space
Monitors the position of the jaw in three dimensions
Represents the spatial position of the mandibular incisal edge relative to the skull
For electromvonrauhic function of this device:
Intended for use for muscles of mastication, especially temporalis, masseter, and digastric
Designed to perform a limited number of functions in dental diagnosis
For use as a stand alone system for clinical monitoring of up to eight different muscles. it is ideally suited for diagnosis and treatment evaluation by recording function/dysfunction of the muscles of the stomatognathic system
The determination of the degree of relaxation of a particular muscle or muscle group at rest
The precise measurement of relative levels of contraction of several muscles during a functional test
For both functions of this device:
Diagnosis and management of TMJIMPD disorders, orthodontic patients, denture patients, and reconstruction patients.
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/K992694 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992694: Modification to K6-I Diagnostic System, Model K6-I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992694
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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