510(k) · Cleared
ClearedNicolet EDX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Natus Neurology Incorporated · GWF Stimulator, Electrical, Evoked Response
Cleared on Jan 22, 2025 as substantially equivalent to K120979 (Carefusion 209, Inc., 2012) and 1 other predicate after a 30-day review. Its family tree reaches back 9 generations to 1980.
- Decided
- Jan 22, 2025
- Review
- 30 days
- Class
- Class II
- Product code
- GWF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K802637 (1980). 28 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK802637 Teca Model-10 ElectromyographTeca, Inc. · 1980
- 5 generations between
- 3 generations backK120979 Carefusion Nicolet EdxCarefusion 209, Inc. · 2012
- 2 generations backK130346 Synergy Focus Desktop Version; Synergy Focus Laptop VersionNatus Neurology Incorporated · 2013
- 1 generation backK243495 Natus Ultrapro S100 (982A0594)Natus Neurology Incorporated · 2024
- This deviceK243982 Nicolet EDXNatus Neurology Incorporated · 2025
Show all 9 generations
- Root · 9 generations backK802637 Teca Model-10 ElectromyographTeca, Inc. · 1980
- 8 generations backK982359 NC-StatNeurometrix, Inc. · 1998
- 7 generations backK013459 Modification of NC-StatNeurometrix, Inc. · 2002
- 6 generations backK041320 Modification to NC-StatNeurometrix, Inc. · 2004
- 5 generations backK060584 NC-StatNeurometrix, Inc. · 2006
- 4 generations backK070109 Neurometrix AdvanceNeurometrix, Inc. · 2008
- 3 generations backK120979 Carefusion Nicolet EdxCarefusion 209, Inc. · 2012
- 2 generations backK130346 Synergy Focus Desktop Version; Synergy Focus Laptop VersionNatus Neurology Incorporated · 2013
- 1 generation backK243495 Natus Ultrapro S100 (982A0594)Natus Neurology Incorporated · 2024
- This deviceK243982 Nicolet EDXNatus Neurology Incorporated · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K802637 | Teca Model-10 Electromyograph | Teca, Inc. | 1980 | — |
| −8 | K982359 | NC-Stat | Neurometrix, Inc. | 1998 | — |
| −7 | K013459 | Modification of NC-Stat | Neurometrix, Inc. | 2002 | — |
| −6 | K041320 | Modification to NC-Stat | Neurometrix, Inc. | 2004 | — |
| −5 | K060584 | NC-Stat | Neurometrix, Inc. | 2006 | — |
| −4 | K070109 | Neurometrix Advance | Neurometrix, Inc. | 2008 | — |
| −3 | K120979 | Carefusion Nicolet Edx | Carefusion 209, Inc. | 2012 | — |
| −2 | K130346 | Synergy Focus Desktop Version; Synergy Focus Laptop Version | Natus Neurology Incorporated | 2013 | — |
| −1 | K243495 | Natus Ultrapro S100 (982A0594) | Natus Neurology Incorporated | 2024 | — |
| 0 (this device) | K243982 | Nicolet EDX | Natus Neurology Incorporated | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 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 GWF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GWF device
- #1 K263010 ISIS Headboxes, ISIS Neurostimulator, ISIS…score 17.5 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K120979 | Carefusion Nicolet EdxSummary page 5…OLT GWJ GWE GZP Predicate Devices: K120979 Carefusion Nicolet EDX with Synergy Software K243495 Natus UltraPro S100… | 2012 |
| * | K243495 | Natus Ultrapro S100 (982A0594)Summary page 5…GWE GZP Predicate Devices: K120979 Carefusion Nicolet EDX with Synergy Software K243495 Natus UltraPro S100 Natus Neurology Incorporated | 3150 Pleasant View Road, Middleton, WI 53562 | USA | na… | 2024 |
| † | K232285 | U-Lite PRO | 2024 |
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 45 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 2 of the 28 ancestors have a recall of any class.
- 3 other devices also cite its predicate K120979.
How does its category compare?
All GWF devicesGWF Stimulator, Electrical, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · GWF
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWF
92in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWF
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWF
1,034in 2025
MAUDE reports naming product code GWF, 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 | 3 | 69 | 0 | 2 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 5 | 178 | 0 | 1 |
| 2010 | 3 | 269 | 0 | 4 |
| 2011 | 2 | — | 0 | 10 |
| 2012 | 4 | 230 | 1 | 44 |
| 2013 | 3 | 174 | 0 | 89 |
| 2014 | 1 | — | 0 | 25 |
| 2015 | 2 | — | 1 | 22 |
| 2016 | 1 | — | 0 | 20 |
| 2017 | 3 | 169 | 0 | 60 |
| 2018 | 0 | — | 0 | 58 |
| 2019 | 1 | — | 0 | 94 |
| 2020 | 1 | — | 0 | 65 |
| 2021 | 2 | — | 0 | 55 |
| 2022 | 2 | — | 0 | 45 |
| 2023 | 2 | — | 0 | 150 |
| 2024 | 4 | 92 | 0 | 854 |
| 2025 | 1 | — | 0 | 1,034 |
| 2026 | 3 | 125 | 2 | — |
What is it indicated for?
The Nicolet EDX is intended for the acquisition, display, analysis, storage, reporting, and management of electrophysiological information from the human nervous and muscular systems including Nerve Conduction (NCS), Electromyography (EMG), Evoked Potentials (EP), Autonomic Responses and Intra-Operative Monitoring including Electroencephalography (EEG). Evoked Potentials (EP) includes Visual Evoked Potentials (VEP), Auditory Evoked Potentials (AEP)…
Read the full statement (206 words)
The Nicolet EDX is intended for the acquisition, display, analysis, storage, reporting, and management of electrophysiological information from the human nervous and muscular systems including Nerve Conduction (NCS), Electromyography (EMG), Evoked Potentials (EP), Autonomic Responses and Intra-Operative Monitoring including Electroencephalography (EEG).
Evoked Potentials (EP) includes Visual Evoked Potentials (VEP), Auditory Evoked Potentials (AEP), Somatosensory Evoked Potentials (SEP), Electroretinography (ERG), Electrooculography (EOG), P300, Motor Evoked Potentials (MEP) and Contingent Negative Variation (CNV). The Nicolet EDX with Natus Elite Software may be used to determine autonomic responses to physiologic stimuli by measuring the change in electrical resistance between two electrodes (Galvanic Skin Response and Sympathetic Skin Response). Autonomic testing also includes assessment of RR Interval variability. The Nicolet EDX with Natus Elite Software is used to detect the physiologic function of the nervous system, for the location of neural structures during surgery, and to support the diagnosis of neuromuscular disease or condition.
The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the nerve; Electromyography measures the electrical activity of the muscle and Evoked Potentials measure electrical activity from the Central Nervous System.
The Nicolet EDX with Natus Elite Software is intended to be used by a qualified healthcare provider.
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/K243982 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243982: Nicolet EDX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243982
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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