510(k) · Cleared
ClearedJ4 Myo-Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Myo-Tronics Research, Inc. · NUW Stimulator, Muscle, Powered, Dental
Cleared on Nov 19, 1984 after a 167-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Nov 19, 1984
- Review
- 167 days
- Class
- Class II
- Product code
- NUW
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK842223 J4 Myo-MonitorMyo-Tronics Research, Inc. · 1984
- Descendant · cites it directly · 7 of its ownK031998 Model J-5 Mvo-MonitorMyotronics-Noromed, Inc. · 2003
- Descendant · 2 generations on · 2 of its ownK092675 GrindcareMedotech A/S · 2010
- Descendant · 2 generations on · 1 of its ownK203525 D functionIto Co., Ltd. · 2021
- Descendant · 3 generations on · 0 of its ownK243290 BTL-785MJBTL Industries, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK163448 GrindCare SystemSunstar Suisse S.A. · 2017
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K031998Model J-5 Mvo-MonitorMyotronics-Noromed, Inc. · 2003 · cites it directly7descendants
- K092675GrindcareMedotech A/S · 2010 · 2 generations on2descendants
- K203525D functionIto Co., Ltd. · 2021 · 2 generations on1descendant
- K243290BTL-785MJBTL Industries, Inc. · 2025 · 3 generations on0descendants
- K163448GrindCare SystemSunstar Suisse S.A. · 2017 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K842223 | J4 Myo-Monitor | Myo-Tronics Research, Inc. | 1984 | — |
| +1 | K031998 | Model J-5 Mvo-Monitor | Myotronics-Noromed, Inc. | 2003 | — |
| +2 | K092675 | Grindcare | Medotech A/S | 2010 | — |
| +2 | K203525 | D function | Ito Co., Ltd. | 2021 | — |
| +3 | K243290 | BTL-785MJ | BTL Industries, Inc. | 2025 | — |
| +3 | K163448 | GrindCare System | Sunstar Suisse S.A. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
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?
- Of its descendants, K031998 (Myotronics-Noromed, Inc., 2003) has gone furthest, with 7 descendants of its own.
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 | — |
https://510kreport.com/device/K842223 · printed Nov 5, 2026
Cite this page
510(k) Report. “K842223: J4 Myo-Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K842223
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026