510(k) · Cleared
ClearedModel J-5 Mvo-Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Myotronics-Noromed, Inc. · NUW Stimulator, Muscle, Powered, Dental
Cleared on Jul 24, 2003 as substantially equivalent to K842223 (Myo-Tronics Research, Inc., 1984) after a 27-day review. Its family tree reaches back 1 generation to 1984. 7 later devices descend from it.
- Decided
- Jul 24, 2003
- Review
- 27 days
- Class
- Class II
- Product code
- NUW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K842223 (1984). 7 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK842223 J4 Myo-MonitorMyo-Tronics Research, Inc. · 1984
- This deviceK031998 Model J-5 Mvo-MonitorMyotronics-Noromed, Inc. · 2003
- Descendant · cites it directly · 2 of its ownK092675 GrindcareMedotech A/S · 2010
- Descendant · cites it directly · 1 of its ownK203525 D functionIto Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK243290 BTL-785MJBTL Industries, Inc. · 2025
- Descendant · 2 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
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K092675GrindcareMedotech A/S · 2010 · cites it directly2descendants
- K203525D functionIto Co., Ltd. · 2021 · cites it directly1descendant
- K243290BTL-785MJBTL Industries, Inc. · 2025 · 2 generations on0descendants
- K163448GrindCare SystemSunstar Suisse S.A. · 2017 · 2 generations on0descendants
- K113677Grindcare MeasureMedotech A/S · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K842223 | J4 Myo-Monitor | Myo-Tronics Research, Inc. | 1984 | — |
| 0 (this device) | K031998 | Model J-5 Mvo-Monitor | Myotronics-Noromed, Inc. | 2003 | — |
| +1 | K092675 | Grindcare | Medotech A/S | 2010 | — |
| +1 | K203525 | D function | Ito Co., Ltd. | 2021 | — |
| +2 | K243290 | BTL-785MJ | BTL Industries, Inc. | 2025 | — |
| +2 | 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 |
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 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 NUW? 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 NUW device
- #1 K243290 BTL-785MJscore 9.9 · 3 generations · no Class I recall
- #2 Held for the reportin 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 |
|---|---|---|---|
| * | K842223 | J4 Myo-MonitorSummary page 3…Tukwila, WA 98 188 Telephone (206) 243-42 14 Contact: Mr. Fray Adib, President Device: Model J-5 Myo-monitor Legally marketed predicate device: Model 5-4 Myo-monitor (K842223) Myotronics- Noromed, Inc. Description of the Device: The device is an ultra-low frequency, battery operated muscle stimulator u… | 1984 |
What descends from it? (7)
4 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?
How does its category compare?
All NUW devicesNUW Stimulator, Muscle, Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NUW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NUW
Too few NUW 510(k)s in any year since 2007 to give a median.
Recalls per year · NUW
No recall names NUW since 2007.
Adverse event reports per year · NUW
No MAUDE report names NUW 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 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
To treat Temporomandibular Joint (TMJ) dysfunction and associated pain
To relieve symptoms associated with muscle spasm
To relax muscles and establish a physiologic occlusion
To take occlusal registrations
To take denture impressions
To increase local blood circulation
To maintain or increase mandibular range of motion
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031998 · printed Nov 3, 2026
Cite this page
510(k) Report. “K031998: Model J-5 Mvo-Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K031998
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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