510(k) · Cleared
ClearedFocus Emg Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleemg, LLC USA · IKN Electromyograph, Diagnostic
Cleared on Mar 4, 2011 as substantially equivalent to K073415 (Eb Neuro S.P.A., 2008) and 1 other predicate after a 175-day review. Its family tree reaches back 2 generations to 1993. 34 later devices descend from it.
- Decided
- Mar 4, 2011
- Review
- 175 days
- Class
- Class II
- Product code
- IKN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K922488 (1993). 3 ancestors in all. 34 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK922488 Phasis ElectromyographBiosound, Inc. · 1993
- 1 generation backK073415 Nemus System; Nemus PC PeripheralEb Neuro S.P.A. · 2008
- This deviceK102610 Focus Emg DeviceTeleemg, LLC USA · 2011
- Descendant · cites it directly · 30 of its ownK112052 Carefusion Nicolet EdxCarefusion 209, Inc. · 2012
- Descendant · 2 generations on · 12 of its ownK162383 Cadwell Sierra Summit, Cadwell Sierra AscentCadwell Industries, Inc. · 2017
- Descendant · 2 generations on · 12 of its ownK120979 Carefusion Nicolet EdxCarefusion 209, Inc. · 2012
- Descendant · 3 generations on · 9 of its ownK182542 The EPAD 2 SystemSafeop Surgical, Inc. · 2019
- Descendant · 3 generations on · 7 of its ownK162199 Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc. · 2017 · Recalled
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K112052Carefusion Nicolet EdxCarefusion 209, Inc. · 2012 · cites it directly30descendants
- K162383Cadwell Sierra Summit, Cadwell Sierra AscentCadwell Industries, Inc. · 2017 · 2 generations on12descendants
- K120979Carefusion Nicolet EdxCarefusion 209, Inc. · 2012 · 2 generations on12descendants
- K182542The EPAD 2 SystemSafeop Surgical, Inc. · 2019 · 3 generations on9descendants
- K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc. · 2017 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922488 | Phasis Electromyograph | Biosound, Inc. | 1993 | — |
| −1 | K073415 | Nemus System; Nemus PC Peripheral | Eb Neuro S.P.A. | 2008 | — |
| 0 (this device) | K102610 | Focus Emg Device | Teleemg, LLC USA | 2011 | — |
| +1 | K112052 | Carefusion Nicolet Edx | Carefusion 209, Inc. | 2012 | — |
| +2 | K162383 | Cadwell Sierra Summit, Cadwell Sierra Ascent | Cadwell Industries, Inc. | 2017 | — |
| +2 | K120979 | Carefusion Nicolet Edx | Carefusion 209, Inc. | 2012 | — |
| +3 | K182542 | The EPAD 2 System | Safeop Surgical, Inc. | 2019 | — |
| +3 | K162199 | Cascade IOMAX Intraoperative Monitor | Cadwell Industries, Inc. | 2017 | 3 |
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 |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2022 | 5 | 0 |
| 2023 | 5 | 0 |
| 2024 | 4 | 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 |
|---|---|---|---|
| * | K073415 | Nemus System; Nemus PC PeripheralSummary page 1…Diagnostic Electromyograph Classification Name: Diagnostic Electromyograph Product Code: IKN, JXE 3. PREDICATE DEVICES * Nemus System, K073415 * Synergy LT, K98 1405 4. DEvici DESCRIPTION Physical Description The Focus is a 2-channel neurodiagnostic testing system… | 2008 |
| * | K981405 | Synergy LTSummary page 1…omyograph Classification Name: Diagnostic Electromyograph Product Code: IKN, JXE 3. PREDICATE DEVICES * Nemus System, K073415 * Synergy LT, K98 1405 4. DEvici DESCRIPTION Physical Description The Focus is a 2-channel neurodiagnostic testing system designed to enable reliab… | 1998 |
| † | K060584 | NC-Stat | 2006 |
What descends from it? (34)
See all 343 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?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 15.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K112052 (Carefusion 209, Inc., 2012) has gone furthest, with 30 descendants of its own.
- 3 other devices also cite its predicate K073415.
How does its category compare?
All IKN devicesIKN Electromyograph, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
The Focus is intended for use by a healthcare provider to perform nerve conductions and
EMG studies as an aid in the evaluation of patients with diseases of muscle and nerves.
The machine can also use electrical stimulus or sound stimulus for evoked potentials (EP)
studies.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K102610 · printed Nov 5, 2026
Cite this page
510(k) Report. “K102610: Focus Emg Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102610
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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