510(k) · Cleared
ClearedPhysical Monitoring Registration Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maryrose Cusimano, Ph.D./Phil Reaston · IKN Electromyograph, Diagnostic
Cleared on Nov 13, 2002 as substantially equivalent to K002104 (Maryrose Cusimano, Ph.D. & Scott Zeff, 2000) and 4 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1989. 4 later devices descend from it.
- Decided
- Nov 13, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- IKN
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 1 generation to K890495 (1989). 5 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK890495 Nicolet Viking II SystemNicolet Instrument Corp. · 1989
- This deviceK022719 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 · cites it directly · 0 of its ownK123902 Physical Monitoring Registration Unit-S (Pmru-S)Oktx, LLC · 2013
Most influential descendants
Showing 4 of 4 · See all- 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 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K890495 | Nicolet Viking II System | Nicolet Instrument Corp. | 1989 | — |
| 0 (this device) | 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 | — |
| +1 | K123902 | Physical Monitoring Registration Unit-S (Pmru-S) | Oktx, LLC | 2013 | — |
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 |
|---|---|---|
| 2004 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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? (5)
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 |
|---|---|---|---|
| * | K002104 | Combined Physiological Monitoring System | 2000 |
| * | K944787 | Integrated Movement AnalyzerSummary page 1…75) List of Predicate Devices to which we claim substantial equivalence: 1. Combined Physiological Monitoring System (KO02 104) 2. Integrated Movement Analyzer (K944787) 3. Davicon Medic System (K914920) 4. Nuerocom EMG (K90 1732) 5. Nicolet Viking 2 (K8904950 Description of Physical… | 1995 |
| * | K914920 | Biofeedback System/3Summary page 1…h we claim substantial equivalence: 1. Combined Physiological Monitoring System (KO02 104) 2. Integrated Movement Analyzer (K944787) 3. Davicon Medic System (K914920) 4. Nuerocom EMG (K90 1732) 5. Nicolet Viking 2 (K8904950 Description of Physical Monitoring Registration Unit, Device… | 1992 |
| * | K901732 | Emg Accessory for PosturographySummary page 1…ence: 1. Combined Physiological Monitoring System (KO02 104) 2. Integrated Movement Analyzer (K944787) 3. Davicon Medic System (K914920) 4. Nuerocom EMG (K90 1732) 5. Nicolet Viking 2 (K8904950 Description of Physical Monitoring Registration Unit, Device 1 The Physic… | 1991 |
| * | K890495 | Nicolet Viking II SystemSummary page 1…Monitoring System (KO02 104) 2. Integrated Movement Analyzer (K944787) 3. Davicon Medic System (K914920) 4. Nuerocom EMG (K90 1732) 5. Nicolet Viking 2 (K8904950 Description of Physical Monitoring Registration Unit, Device 1 The Physical Monitoring Registration Unit, (… | 1989 |
What descends from it? (4)
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?
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, functional capacity assessment grip and
pinch strength.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022719 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022719: Physical Monitoring Registration Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022719
Report an extraction error
Are you the manufacturer?
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