510(k) · Cleared
ClearedM-SCAN
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Research Associates, Inc. · KZM Device, Muscle Monitoring
Cleared on Jul 25, 2013 as substantially equivalent to K082927 (Bio-Research Associates, Inc., 2009) after a 183-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Jul 25, 2013
- Review
- 183 days
- Class
- Class II
- Product code
- KZM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K003176 (2001). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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? (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 |
|---|---|---|---|
| * | K082927 | Bioemg IiiSummary page 1…yography Regulation Number: 21 CFR 890.1375 Regulation Name: Diagnostic Electromyography Regulatory Class: Class 11 Product Code: KZM Equivalent Device: BioEMG 1ll (K082927) Previous submissions: None Product Description: The M-Scan is a 2-channel, portable, battery operated electromyographic amplif… | 2009 |
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?
- The line of descent spans 12 years and passes through 1 company; a new generation was cleared every 8.1 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All KZM devicesKZM Device, Muscle Monitoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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?
Indications for use: 2 channel, hand held, mobile EMG amplifier
1. To record electrical activity of 2 muscles of the stomatognathic system, especially temporalis or masseter
2. To clinically monitor 2 different muscles as an aid in the diagnosis and treatment evaluation by recording the electrical activity of muscles of the stomatognathic system
3. To determine the degree of relaxation (intra-patient) of 2 muscles at rest
4. To measure relative (intra-patient) levels of activity of 2 muscles during a functional act
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130158 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130158: M-SCAN.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130158
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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