510(k) · Cleared
ClearedPhysical Monitoring Registration Unit-S (Pmru-S)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oktx, LLC · IKN Electromyograph, Diagnostic
Cleared on Sep 13, 2013 as substantially equivalent to K022719 (Maryrose Cusimano, Ph.D./Phil Reaston, 2002) after a 269-day review. Its family tree reaches back 2 generations to 1989.
- Decided
- Sep 13, 2013
- Review
- 269 days
- Class
- Class II
- Product code
- IKN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K890495 (1989). 6 ancestors in all. No later device cites it as a predicate yet.
View 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) | 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 |
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 |
|---|---|---|---|
| * | K022719 | Physical Monitoring Registration UnitSummary page 1…romyography (890.1375) Product code: IKN Class 11 Legally Marketed Predicate Device to which we are claiming equivalence: Physical Monitoring Registration Unit (PMRU) K0227 19, Class 11 Description of Device: The Physical Monitoring Registration Unit-S. (PMRU-S) like the legally cleared PMRU combines s… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 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.
- 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. 2013, 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 range of motion,functional capacity assessment, grip and pinch strength.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123902 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123902: Physical Monitoring Registration Unit-S (Pmru-S).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123902
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