510(k) Report

510(k) · Cleared

Cleared

Neuromaster G1 MEE200

K142624510(k) TraditionalCleared Apr 24, 2015220-day reviewClass II21 CFR 882.1870

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

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.

Descendants, by year cleared 2017: 1 descendant cleared2023: 3 descendants cleared2018: 1 descendant cleared2022: 2 descendants cleared2026: 1 descendant clearedReference device: K962455 · Four-Channel Preamplifier · Cadwell Laboratories, Inc. · 1997Reference device: K040358 · Xltek Protektor Stimulator, Models 10247 & 10248 · Excel Tech., Ltd. · 2004 · recalledReference device: K050798 · Eclipse Neurological Workstation · Axon Systems, Inc. · 2005Reference device: K061173 · Cpivision Digital Imaging System · Communications & Power Industries Canada, Inc. · 2006Reference device: K053363 · Dual-Sided Interhemispheric Subdural Electrodes, Grid Subdural Electrodes, Intraoperative Subdural Electrodes · Ad-Tech Medical Instrument Corp · 2006 · Class I recallReference device: K850342 · Wyler Subdural Strip Electrode · Ad-Tech Medical Instrument Corp · 1985Reference device: K071969 · Sen-4100 Electric Stimulator · Nihon Kohden America, Inc. · 2008Reference device: K083124 · NIM 3.0 · Medtronic Xomed, Inc. · 2009 · recalledReference device: K110410 · MS-120BK Electric Stimulator (Extension Unit) · Nihon Kohden Corp. · 2011Reference device: K111647 · C2 Nervemonitor System with Accessories · Inomed Medizintechnik GmbH · 2011Reference device: K112718 · Nuvasive NVM5 System · Nuvasive, Inc. · 2012Reference device: K120397 · Meb-2300A Neuropack Evoked Potential and Emg Measuring System · Nihon Kohden Corp. · 2012K950208 · Nihon Kohden Neuropack Sigma Meb-5500A Evoked Response & Emg Measuring System · Nihon Kohden America, Inc. · 1995K991899 · Nihon Kohden Meb-2200A Neuropack Evoked Potential & Emg Measuring System with Accessories · Nihon Kohden America, Inc. · 1999 · recalledK051178 · Mee-1000A Neuromaster · Nihon Kohden America, Inc. · 2005 · recalled1995200020052010201520202025
  1. Root · 3 generations backK950208 Nihon Kohden Neuropack Sigma Meb-5500A Evoked Response & Emg…Nihon Kohden America, Inc. · 1995
  2. 2 generations backK991899 Nihon Kohden Meb-2200A Neuropack Evoked Potential & Emg Measuring…Nihon Kohden America, Inc. · 1999 · Recalled
  3. 1 generation backK051178 Mee-1000A NeuromasterNihon Kohden America, Inc. · 2005 · Recalled
  4. This deviceK142624 Neuromaster G1 MEE200Nihon Kohden Corporation · 2015
  5. Descendant · cites it directly · 7 of its ownK162199 Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc. · 2017 · Recalled
  6. Descendant · 2 generations on · 5 of its ownK212166 ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert…Inomed Medizintechnik GmbH · 2022
  7. Descendant · 3 generations on · 1 of its ownK233292 ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert…Inomed Medizintechnik GmbH · 2023
  8. Descendant · 3 generations on · 1 of its ownK221821 ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2022
  9. 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

2017: 12018: 12022: 22023: 32026: 1
2017high 3 (2023) · low 0 (2019)2026

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

GenerationNumberDeviceApplicantDecidedRecalls
−3K950208Nihon Kohden Neuropack Sigma Meb-5500A Evoked Response & Emg Measuring SystemNihon Kohden America, Inc.1995—
−2K991899Nihon Kohden Meb-2200A Neuropack Evoked Potential & Emg Measuring System with…Nihon Kohden America, Inc.19991
−1K051178Mee-1000A NeuromasterNihon Kohden America, Inc.20051
0 (this device)K142624Neuromaster G1 MEE200Nihon Kohden Corporation2015—
+1K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.20173
+2K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH2022—
+3K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH2023—
+3K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.2022—
+2K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
201810
202220
202330
202610
FIG. 1 — Lineage of K142624, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K263010 ISIS Headboxes, ISIS Neurostimulator, ISIS…score 17.5 · 19 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K051178Mee-1000A Neuromaster
Summary 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…
Nihon Kohden America, Inc.20051
†K962455Four-Channel PreamplifierCadwell Laboratories, Inc.1997—
†K040358Xltek Protektor Stimulator, Models 10247 & 10248Excel Tech., Ltd.20041
†K050798Eclipse Neurological WorkstationAxon Systems, Inc.2005—
†K061173Cpivision Digital Imaging SystemCommunications & Power Industries Canada, Inc.2006—
†K053363Dual-Sided Interhemispheric Subdural Electrodes, Grid Subdural Electrodes…Ad-Tech Medical Instrument Corp2006Class I
†K850342Wyler Subdural Strip ElectrodeAd-Tech Medical Instrument Corp1985—
†K071969Sen-4100 Electric StimulatorNihon Kohden America, Inc.2008—
†K083124NIM 3.0Medtronic Xomed, Inc.20093
†K110410MS-120BK Electric Stimulator (Extension Unit)Nihon Kohden Corp.2011—
†K111647C2 Nervemonitor System with AccessoriesInomed Medizintechnik GmbH2011—
†K112718Nuvasive NVM5 SystemNuvasive, Inc.2012—
†K120397Meb-2300A Neuropack Evoked Potential and Emg Measuring SystemNihon Kohden Corp.2012—

Also cleared against K051178: 1 other device →

What descends from it? (8)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.20177

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 devices

GWF 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

2007: 32008: 22009: 52010: 32011: 22012: 42013: 32014: 12015: 22016: 12017: 32019: 12020: 12021: 22022: 22023: 22024: 42025: 12026 (partial year): 3
2007high 5 (2009) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GWF

92in 2024

2007: 69 days median2009: 178 days median2010: 269 days median2012: 230 days median2013: 174 days median2017: 169 days median2024: 92 days median2026 (partial year): 125 days median
2007high 269 (2010) · low 69 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GWF

2so far in 2026, the most since 2007

2012: 12015: 12026 (partial year): 2
2007high 2 (2026) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GWF

1,034in 2025

2007: 22008: 12009: 12010: 42011: 102012: 442013: 892014: 252015: 222016: 202017: 602018: 582019: 942020: 652021: 552022: 452023: 1502024: 8542025: 1,034
2007high 1,034 (2025) · low 1 (2008)2025

MAUDE reports naming product code GWF, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200736902
20082—01
2009517801
2010326904
20112—010
20124230144
20133174089
20141—025
20152—122
20161—020
20173169060
20180—058
20191—094
20201—065
20212—055
20222—045
20232—0150
20244920854
20251—01,034
202631252—

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.

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