510(k) · Cleared
ClearedModel ME 300 Muscle Tester
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Regulatory Strategies, Inc. · HCC Device, Biofeedback
Cleared on Jun 25, 1997 as substantially equivalent to K881416 (Thought Technology, Ltd., 1988) and 1 other predicate after a 1,070-day review. Its family tree reaches back 1 generation to 1983.
- Decided
- Jun 25, 1997
- Review
- 1,070 days
- Class
- Class II
- Product code
- HCC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K832714 (1983). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK832714 Verimed MyoexorciserVerimed Holdings, Inc. · 1983
- This deviceK943535 Model ME 300 Muscle TesterRegulatory Strategies, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K832714 | Verimed Myoexorciser | Verimed Holdings, Inc. | 1983 | — |
| 0 (this device) | K943535 | Model ME 300 Muscle Tester | Regulatory Strategies, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 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 HCC? 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 HCC device
- #1 K233580 A Breathing System (ABS)score 8.1 · 2 generations · no Class I recall
- #2 Held for the reportin 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 |
|---|---|---|---|
| * | K881416 | MyotracSummary page 1…Kuopio o Finland tel: 358 71 282 8959 Submitted by Regulatory Strategies, Inc. Consultant to Mega Electronics, Ltd. Predicate Devices Myotrac from Thought Technology K881416 Myoexcerciser from Verimed K832714 - Device Description The MES300 is a portable, battery powered EMG recorder. Technological… | 1988 |
| * | K832714 | Verimed MyoexorciserSummary page 1…959 Submitted by Regulatory Strategies, Inc. Consultant to Mega Electronics, Ltd. Predicate Devices Myotrac from Thought Technology K881416 Myoexcerciser from Verimed K832714 - Device Description The MES300 is a portable, battery powered EMG recorder. Technological Characteristics The ME300 is an e… | 1983 |
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?
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K881416.
How does its category compare?
All HCC devicesHCC Device, Biofeedback: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HCC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HCC
Too few HCC 510(k)s in any year since 2007 to give a median.
Recalls per year · HCC
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HCC
5in 2024
MAUDE reports naming product code HCC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 2 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 0 | — | 1 | 2 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 2 | — | 1 | 0 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
ME300 is an electronic-device used to gather and display electrophysiological signals obtained from muscle activity. These signals are used in programs related to muscle re-education and relaxation training.
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/K943535 · printed Nov 4, 2026
Cite this page
510(k) Report. “K943535: Model ME 300 Muscle Tester.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K943535
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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