510(k) · Cleared
ClearedComprehensive Neuromuscular Profiler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Technologies Unlimited, Inc. · IKN Electromyograph, Diagnostic
Cleared on Jan 7, 2004 as substantially equivalent to K022719 (Maryrose Cusimano, Ph.D./Phil Reaston, 2002) and 1 other predicate after a 194-day review. Its family tree reaches back 2 generations to 1989. 2 later devices descend from it.
- Decided
- Jan 7, 2004
- Review
- 194 days
- Class
- Class II
- Product code
- IKN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K890495 (1989). 6 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK890495 Nicolet Viking II SystemNicolet Instrument Corp. · 1989
- 1 generation backK022719 Physical Monitoring Registration UnitMaryrose Cusimano, Ph.D./Phil Reaston · 2002
- This deviceK031995 Comprehensive Neuromuscular ProfilerMedical Technologies Unlimited, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK113074 Cmap ProMedical Technologies, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK173510 BioStamp nPointMc10, Inc. · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K890495 | Nicolet Viking II System | Nicolet Instrument Corp. | 1989 | — |
| −1 | K022719 | Physical Monitoring Registration Unit | Maryrose Cusimano, Ph.D./Phil Reaston | 2002 | — |
| 0 (this device) | K031995 | Comprehensive Neuromuscular Profiler | Medical Technologies Unlimited, Inc. | 2004 | — |
| +1 | K113074 | Cmap Pro | Medical Technologies, Inc. | 2012 | — |
| +2 | K173510 | BioStamp nPoint | Mc10, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2018 | 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 IKN? 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? (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 |
|---|---|---|---|
| * | K022719 | Physical Monitoring Registration UnitSummary page 1…ssification Name: Diagnostic Eletromyograph (890.1375) List of Predicate Devices to which we claim substantial equivalence 1. Physical Monitoring Registration Unit (K0227 19) 2. Combined Physiological Monitoring System (KO02 104) Description of Device The Comprehensive Neuromuscular Profiler is… | 2002 |
| * | K002104 | Combined Physiological Monitoring System | 2000 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113074 | Cmap Pro | 2012 | 1 |
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 15 years and passes through 3 companies; a new generation was cleared every 13.7 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K113074 (Medical Technologies, Inc., 2012) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K022719.
How does its category compare?
All IKN devicesIKN Electromyograph, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IKN
3in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · IKN
188in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IKN
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IKN
3in 2025
MAUDE reports naming product code IKN, 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 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 1 | 1 |
| 2011 | 2 | — | 0 | 4 |
| 2012 | 1 | — | 0 | 4 |
| 2013 | 2 | — | 0 | 24 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 13 |
| 2016 | 0 | — | 0 | 11 |
| 2017 | 3 | 188 | 0 | 2 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Surface electromyography with range of motion tracking, functional capacity and pinch and grip strength measuring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031995 · printed Nov 3, 2026
Cite this page
510(k) Report. “K031995: Comprehensive Neuromuscular Profiler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K031995
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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