510(k) · Cleared
ClearedCombined Physiological Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maryrose Cusimano, Ph.D. & Scott Zeff · IKN Electromyograph, Diagnostic
Cleared on Oct 10, 2000 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Oct 10, 2000
- Review
- 90 days
- Class
- Class II
- Product code
- IKN
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK002104 Combined Physiological Monitoring SystemMaryrose Cusimano, Ph.D. & Scott Zeff · 2000
- Descendant · cites it directly · 4 of its ownK022719 Physical Monitoring Registration UnitMaryrose Cusimano, Ph.D./Phil Reaston · 2002
- Descendant · cites it directly · 2 of its ownK031995 Comprehensive Neuromuscular ProfilerMedical Technologies Unlimited, Inc. · 2004
- Descendant · 2 generations on · 1 of its ownK113074 Cmap ProMedical Technologies, Inc. · 2012
- Descendant · 3 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 · cites it directly2descendants
- K113074Cmap ProMedical Technologies, Inc. · 2012 · 2 generations on1descendant
- K173510BioStamp nPointMc10, Inc. · 2018 · 3 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) | K002104 | Combined Physiological Monitoring System | Maryrose Cusimano, Ph.D. & Scott Zeff | 2000 | — |
| +1 | K022719 | Physical Monitoring Registration Unit | Maryrose Cusimano, Ph.D./Phil Reaston | 2002 | — |
| +1 | K031995 | Comprehensive Neuromuscular Profiler | Medical Technologies Unlimited, Inc. | 2004 | — |
| +2 | K113074 | Cmap Pro | Medical Technologies, Inc. | 2012 | — |
| +3 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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/K002104 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002104: Combined Physiological Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002104
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