510(k) · Cleared
ClearedNeuromaster G1 MEE200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nihon Kohden Corporation · GWF Stimulator, Electrical, Evoked Response
Cleared on Apr 24, 2015 as substantially equivalent to K051178 (Nihon Kohden America, Inc., 2005) after a 220-day review. Its family tree reaches back 3 generations to 1995. 8 later devices descend from it.
- Decided
- Apr 24, 2015
- Review
- 220 days
- Class
- Class II
- Product code
- GWF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K950208 (1995). 8 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK950208 Nihon Kohden Neuropack Sigma Meb-5500A Evoked Response & Emg…Nihon Kohden America, Inc. · 1995
- 2 generations backK991899 Nihon Kohden Meb-2200A Neuropack Evoked Potential & Emg Measuring…Nihon Kohden America, Inc. · 1999 · Recalled
- 1 generation backK051178 Mee-1000A NeuromasterNihon Kohden America, Inc. · 2005 · Recalled
- This deviceK142624 Neuromaster G1 MEE200Nihon Kohden Corporation · 2015
- Descendant · cites it directly · 7 of its ownK162199 Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 5 of its ownK212166 ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert…Inomed Medizintechnik GmbH · 2022
- Descendant · 3 generations on · 1 of its ownK233292 ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert…Inomed Medizintechnik GmbH · 2023
- Descendant · 3 generations on · 1 of its ownK221821 ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK263010 ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert…inomed Medizintechnik GmbH · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc. · 2017 · cites it directly7descendants
- K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH · 2022 · 2 generations on5descendants
- K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH · 2023 · 3 generations on1descendant
- K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2022 · 3 generations on1descendant
- K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K950208 | Nihon Kohden Neuropack Sigma Meb-5500A Evoked Response & Emg Measuring System | Nihon Kohden America, Inc. | 1995 | — |
| −2 | K991899 | Nihon Kohden Meb-2200A Neuropack Evoked Potential & Emg Measuring System with… | Nihon Kohden America, Inc. | 1999 | 1 |
| −1 | K051178 | Mee-1000A Neuromaster | Nihon Kohden America, Inc. | 2005 | 1 |
| 0 (this device) | K142624 | Neuromaster G1 MEE200 | Nihon Kohden Corporation | 2015 | — |
| +1 | K162199 | Cascade IOMAX Intraoperative Monitor | Cadwell Industries, Inc. | 2017 | 3 |
| +2 | K212166 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | Inomed Medizintechnik GmbH | 2022 | — |
| +3 | K233292 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | Inomed Medizintechnik GmbH | 2023 | — |
| +3 | K221821 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2022 | — |
| +2 | K263010 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | inomed Medizintechnik GmbH | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K051178 | Mee-1000A NeuromasterSummary page 7…gn recalls. Table 1 Table of Predicates 510(k) Product 510(k) Holder Neuromaster MEE1000 Neural Function K051178 Nihon Kohden America, Inc Measuring System K962455 Cadwell Cascad… | 2005 |
| † | K962455 | Four-Channel Preamplifier | 1997 |
| † | K040358 | Xltek Protektor Stimulator, Models 10247 & 10248 | 2004 |
| † | K050798 | Eclipse Neurological Workstation | 2005 |
| † | K061173 | Cpivision Digital Imaging System | 2006 |
| † | K053363 | Dual-Sided Interhemispheric Subdural Electrodes, Grid Subdural Electrodes… | 2006 |
| † | K850342 | Wyler Subdural Strip Electrode | 1985 |
| † | K071969 | Sen-4100 Electric Stimulator | 2008 |
| † | K083124 | NIM 3.0 | 2009 |
| † | K110410 | MS-120BK Electric Stimulator (Extension Unit) | 2011 |
| † | K111647 | C2 Nervemonitor System with Accessories | 2011 |
| † | K112718 | Nuvasive NVM5 System | 2012 |
| † | K120397 | Meb-2300A Neuropack Evoked Potential and Emg Measuring System | 2012 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162199 | Cascade IOMAX Intraoperative Monitor | 2017 | 7 |
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 20 years and passes through 2 companies; a new generation was cleared every 6.0 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K162199 (Cadwell Industries, Inc., 2017) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K051178.
How does its category compare?
All GWF devicesGWF Stimulator, Electrical, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Neuromaster G1 MEE 2000 Neural Function Measuring System is intended to monitor, record, and display the bioelectric signals produced by sensory and motor pathways in the operating room, critical care, and other areas where continuous monitoring is needed. The system measures and displays electric/auditory/visual evoked potential (EP), electroencephalography (EEG), and electromyography (EMG), skin temperature of distal portion of extremities, SpO2…
Read the full statement (528 words)
The Neuromaster G1 MEE 2000 Neural Function Measuring System is intended to monitor, record, and display the bioelectric signals produced by sensory and motor pathways in the operating room, critical care, and other areas where continuous monitoring is needed. The system measures and displays electric/auditory/visual evoked potential (EP), electroencephalography (EEG), and electromyography (EMG), skin temperature of distal portion of extremities, SpO2, and ETCO2 to provide health care professionals with information to help assess a patient’s neurological status. The system is used as a nerve stimulator for surgical procedures and brain mapping during treatment of patients with seizure disorders and used for the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.
* EEG - The device may also measure and record the electrical activities of the patient's brain obtained by placing two or more electrodes on the head (EEG).
* EP-Electrical/ Auditory/ Visual - Continuous and/or periodic measurements of evoked potential activities are displayed and stored. The device applies an electrical stimulus to a patient through commercially available skin electrodes for the purpose of measuring the evoked response. The photic stimulator is used to generate and display a shifting pattern or to apply a brief light stimulus to a patient's eye and the auditory stimulator produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.
* Free Run EMG - The Free Run EMG function identifies spontaneous EMG activity of nerves by continually displaying a live stream waveform of any mechanically induced myotome contractions.
* CoMEP - Cortical stimulation techniques for cortical mapping are used at “Low Output” for placement of electrodes during surgical procedures and for brain mapping during treatment of patients with seizure disorders.
* TcMEP - Transcranial electrical stimulation techniques for motor evoked potentials (TcMEP) are used at “TcMEP Output” for the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.”
* Nerve conduction study - The device is intended to measure and display nerve conduction time by applying a stimulus to a patient's peripheral nerve. This device includes the stimulator and the electronic processing equipment for measuring and displaying the nerve conduction time.
* SpO2 - When the SpO2 adapter and finger and toe probe for SpO2 measurement are used, oxygen saturation information is automatically measured and displayed.
* EtCO2 - When the CO2 adapter and sensor for EtCO2 measurement are used, end-tidal carbon dioxide of respiratory gas information is automatically measured and displayed.
+ Skin temperature - When the skin temperature sensor for skin temperature measurement is used, skin temperature information is automatically measured and displayed.
* Remote reader — The remote reader function provides real time remote access to the system for a monitoring physician outside of the operating room.
The system is intended for use by medical personnel within a hospital, laboratory, clinic or nursing home setting or outside of a medical facility under direct supervision of a medical professional.
The system is available for use on any patient as determined by the medical professional including adults and children of all ages.
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/K142624 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142624: Neuromaster G1 MEE200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142624
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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