510(k) · Cleared
ClearedCmap Pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Technologies, Inc. · IKN Electromyograph, Diagnostic
Cleared on Feb 2, 2012 as substantially equivalent to K031995 (Medical Technologies Unlimited, Inc., 2004) after a 108-day review. Its family tree reaches back 3 generations to 1989. 1 later device descends from it.
- Decided
- Feb 2, 2012
- Review
- 108 days
- Class
- Class II
- Product code
- IKN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K890495 (1989). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK890495 Nicolet Viking II SystemNicolet Instrument Corp. · 1989
- 2 generations backK022719 Physical Monitoring Registration UnitMaryrose Cusimano, Ph.D./Phil Reaston · 2002
- 1 generation backK031995 Comprehensive Neuromuscular ProfilerMedical Technologies Unlimited, Inc. · 2004
- This deviceK113074 Cmap ProMedical Technologies, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK173510 BioStamp nPointMc10, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- K173510BioStamp nPointMc10, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K890495 | Nicolet Viking II System | Nicolet Instrument Corp. | 1989 | — |
| −2 | K022719 | Physical Monitoring Registration Unit | Maryrose Cusimano, Ph.D./Phil Reaston | 2002 | — |
| −1 | K031995 | Comprehensive Neuromuscular Profiler | Medical Technologies Unlimited, Inc. | 2004 | — |
| 0 (this device) | K113074 | Cmap Pro | Medical Technologies, Inc. | 2012 | — |
| +1 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K031995 | Comprehensive Neuromuscular ProfilerSummary page 1…myograph ( 21 CFR 890.1375) Predicate Device: Medical Technologies Unlimited Comprehensive Neuromuscular Profiler (CNMP) Predicate Device 510(k) number K031995 3. Device Description: The CMAP ProT is a stand-alone, battery operated dynamic muscle function monitoring system,… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173510 | BioStamp nPoint | 2018 | 0 |
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 23 years and passes through 4 companies; a new generation was cleared every 8.1 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K173510 (Mc10, Inc., 2018) has gone furthest, with 0 descendants of its own.
How does its category compare?
All IKN devicesIKN Electromyograph, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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 video recording, range of motion tracking, isometric functional testing and pinch and grip strength measuring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113074 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113074: Cmap Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113074
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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