De Novo · Granted
GrantedMyocene
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Myocene · SDX Neuromuscular Stimulator And Exercise Evaluation System
Granted on Jan 17, 2025 as a new device type through De Novo after a 540-day review.
- Decided
- Jan 17, 2025
- Review
- 540 days
- Class
- Class II
- Product code
- SDX
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo 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 SDX? 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
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.
How does its category compare?
All SDX devicesSDX Neuromuscular Stimulator And Exercise Evaluation System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · SDX
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SDX
Too few SDX 510(k)s in any year since 2007 to give a median.
Recalls per year · SDX
No recall names SDX since 2007.
Adverse event reports per year · SDX
No MAUDE report names SDX 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 | 0 | — | 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?
The Myocene device is intended to provide objective measures of muscle fatigue to inform athletic training decisions by coaches and athletes. It is for applications in sport practice, to be used on healthy individuals (athletes), 15 years of age or older, to carry out tests of the extensor muscles of the knee by quantitatively measuring the force of contraction of the healthy quadriceps muscles generated by voluntary contractions and induced by a specific associated powered muscle stimulator, and by using these forces to compute objective measures of quadriceps muscle fatigue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN230051 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN230051: Myocene.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN230051
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026