510(k) · Cleared
ClearedNemus System; Nemus PC Peripheral
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eb Neuro S.P.A. · IKN Electromyograph, Diagnostic
Cleared on May 23, 2008 as substantially equivalent to K922488 (Biosound, Inc., 1993) and 1 other predicate after a 171-day review. Its family tree reaches back 1 generation to 1993. 40 later devices descend from it.
- Decided
- May 23, 2008
- Review
- 171 days
- Class
- Class II
- Product code
- IKN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K922488 (1993). 2 ancestors in all. 40 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK922488 Phasis ElectromyographBiosound, Inc. · 1993
- This deviceK073415 Nemus System; Nemus PC PeripheralEb Neuro S.P.A. · 2008
- Descendant · cites it directly · 34 of its ownK102610 Focus Emg DeviceTeleemg, LLC USA · 2011
- Descendant · 2 generations on · 30 of its ownK112052 Carefusion Nicolet EdxCarefusion 209, Inc. · 2012
- Descendant · 3 generations on · 12 of its ownK162383 Cadwell Sierra Summit, Cadwell Sierra AscentCadwell Industries, Inc. · 2017
- Descendant · 3 generations on · 12 of its ownK120979 Carefusion Nicolet EdxCarefusion 209, Inc. · 2012
- Descendant · 4 generations on · 9 of its ownK182542 The EPAD 2 SystemSafeop Surgical, Inc. · 2019
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- K102610Focus Emg DeviceTeleemg, LLC USA · 2011 · cites it directly34descendants
- K112052Carefusion Nicolet EdxCarefusion 209, Inc. · 2012 · 2 generations on30descendants
- K162383Cadwell Sierra Summit, Cadwell Sierra AscentCadwell Industries, Inc. · 2017 · 3 generations on12descendants
- K120979Carefusion Nicolet EdxCarefusion 209, Inc. · 2012 · 3 generations on12descendants
- K182542The EPAD 2 SystemSafeop Surgical, Inc. · 2019 · 4 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922488 | Phasis Electromyograph | Biosound, Inc. | 1993 | — |
| 0 (this device) | K073415 | Nemus System; Nemus PC Peripheral | Eb Neuro S.P.A. | 2008 | — |
| +1 | K102610 | Focus Emg Device | Teleemg, LLC USA | 2011 | — |
| +2 | K112052 | Carefusion Nicolet Edx | Carefusion 209, Inc. | 2012 | — |
| +3 | K162383 | Cadwell Sierra Summit, Cadwell Sierra Ascent | Cadwell Industries, Inc. | 2017 | — |
| +3 | K120979 | Carefusion Nicolet Edx | Carefusion 209, Inc. | 2012 | — |
| +4 | K182542 | The EPAD 2 System | Safeop Surgical, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2022 | 5 | 0 |
| 2023 | 5 | 0 |
| 2024 | 6 | 0 |
| 2025 | 1 | 0 |
| 2026 | 5 | 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? (2)
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 |
|---|---|---|---|
| * | K922488 | Phasis ElectromyographSummary page 1…ification Number: IKN 807.92(a)(3) Predicate Device(s) Esaote Biomedica PHASIS K922488 Oxford Instruments PLC Sinergy LT K98 1405 Additional Substantial Equivalence Information is… | 1993 |
| * | K981405 | Synergy LTSummary page 1…Predicate Device(s) Esaote Biomedica PHASIS K922488 Oxford Instruments PLC Sinergy LT K98 1405 Additional Substantial Equivalence Information is provided in the following Substantial Equivalence Comparison Table. === Page… | 1998 |
What descends from it? (40)
See all 404 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. 2008, 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?
NEMUS systems are diagnostic medical systems able to detect the electric signals produced by the peripheral nerve system and by skeletal muscles.
The NEMUS system is intended to monitor, record and display the bioelectric signal produced by the muscles, to stimulate peripheral nerves, and to monitor, record and display the electrical activity produced by nerves to aid the clinician in the diagnosis and prognosis of neuromuscular diseases (EMG). The device may use electrical stimulus or sound stimulus for use in evoked response measurements (EP).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073415 · printed Nov 5, 2026
Cite this page
510(k) Report. “K073415: Nemus System; Nemus PC Peripheral.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K073415
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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