510(k) · Cleared
ClearedIntegrated Movement Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maryrose · IKN Electromyograph, Diagnostic
Cleared on Jul 7, 1995 after a 282-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.
- Decided
- Jul 7, 1995
- Review
- 282 days
- Class
- Class II
- Product code
- IKN
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK944787 Integrated Movement AnalyzerMaryrose · 1995
- Descendant · cites it directly · 4 of its ownK022719 Physical Monitoring Registration UnitMaryrose Cusimano, Ph.D./Phil Reaston · 2002
- Descendant · 2 generations on · 2 of its ownK031995 Comprehensive Neuromuscular ProfilerMedical Technologies Unlimited, Inc. · 2004
- Descendant · 3 generations on · 1 of its ownK113074 Cmap ProMedical Technologies, Inc. · 2012
- Descendant · 4 generations on · 0 of its ownK173510 BioStamp nPointMc10, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK123902 Physical Monitoring Registration Unit-S (Pmru-S)Oktx, LLC · 2013
Most influential descendants
Showing 5 of 5 · See all- K022719Physical Monitoring Registration UnitMaryrose Cusimano, Ph.D./Phil Reaston · 2002 · cites it directly4descendants
- K031995Comprehensive Neuromuscular ProfilerMedical Technologies Unlimited, Inc. · 2004 · 2 generations on2descendants
- K113074Cmap ProMedical Technologies, Inc. · 2012 · 3 generations on1descendant
- K173510BioStamp nPointMc10, Inc. · 2018 · 4 generations on0descendants
- K123902Physical Monitoring Registration Unit-S (Pmru-S)Oktx, LLC · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K944787 | Integrated Movement Analyzer | Maryrose | 1995 | — |
| +1 | K022719 | Physical Monitoring Registration Unit | Maryrose Cusimano, Ph.D./Phil Reaston | 2002 | — |
| +2 | K031995 | Comprehensive Neuromuscular Profiler | Medical Technologies Unlimited, Inc. | 2004 | — |
| +3 | K113074 | Cmap Pro | Medical Technologies, Inc. | 2012 | — |
| +4 | K173510 | BioStamp nPoint | Mc10, Inc. | 2018 | — |
| +2 | K123902 | Physical Monitoring Registration Unit-S (Pmru-S) | Oktx, LLC | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022719 | Physical Monitoring Registration Unit | 2002 | 4 |
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?
- Of its descendants, K022719 (Maryrose Cusimano, Ph.D./Phil Reaston, 2002) has gone furthest, with 4 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.
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 | — |
https://510kreport.com/device/K944787 · printed Nov 4, 2026
Cite this page
510(k) Report. “K944787: Integrated Movement Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K944787
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026