510(k) · Cleared
Recalled · Class II · 2012Mee-1000A Neuromaster
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nihon Kohden America, Inc. · GWF Stimulator, Electrical, Evoked Response
Cleared on Aug 17, 2005 as substantially equivalent to K991899 (Nihon Kohden America, Inc., 1999) after a 100-day review. Its family tree reaches back 2 generations to 1995. 10 later devices descend from it. It has been recalled once.
- Decided
- Aug 17, 2005
- Review
- 100 days
- Class
- Class II
- Product code
- GWF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K950208 (1995). 10 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK950208 Nihon Kohden Neuropack Sigma Meb-5500A Evoked Response & Emg…Nihon Kohden America, Inc. · 1995
- 1 generation backK991899 Nihon Kohden Meb-2200A Neuropack Evoked Potential & Emg Measuring…Nihon Kohden America, Inc. · 1999 · Recalled
- This deviceK051178 Mee-1000A NeuromasterNihon Kohden America, Inc. · 2005
- Descendant · cites it directly · 8 of its ownK142624 Neuromaster G1 MEE200Nihon Kohden Corporation · 2015
- Descendant · 2 generations on · 7 of its ownK162199 Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc. · 2017 · Recalled
- Descendant · 3 generations on · 5 of its ownK212166 ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert…Inomed Medizintechnik GmbH · 2022
- Descendant · 4 generations on · 1 of its ownK233292 ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert…Inomed Medizintechnik GmbH · 2023
- Descendant · 4 generations on · 1 of its ownK221821 ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2022
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K142624Neuromaster G1 MEE200Nihon Kohden Corporation · 2015 · cites it directly8descendants
- K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc. · 2017 · 2 generations on7descendants
- K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH · 2022 · 3 generations on5descendants
- K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH · 2023 · 4 generations on1descendant
- K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2022 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K950208 | Nihon Kohden Neuropack Sigma Meb-5500A Evoked Response & Emg Measuring System | Nihon Kohden America, Inc. | 1995 | — |
| −1 | K991899 | Nihon Kohden Meb-2200A Neuropack Evoked Potential & Emg Measuring System with… | Nihon Kohden America, Inc. | 1999 | 1 |
| 0 (this device) | K051178 | Mee-1000A Neuromaster | Nihon Kohden America, Inc. | 2005 | — |
| +1 | K142624 | Neuromaster G1 MEE200 | Nihon Kohden Corporation | 2015 | — |
| +2 | K162199 | Cascade IOMAX Intraoperative Monitor | Cadwell Industries, Inc. | 2017 | 3 |
| +3 | K212166 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | Inomed Medizintechnik GmbH | 2022 | — |
| +4 | K233292 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | Inomed Medizintechnik GmbH | 2023 | — |
| +4 | K221821 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | K991899 | Nihon Kohden Meb-2200A Neuropack Evoked Potential & Emg Measuring System with AccessoriesSummary page 1…sponse Auditory Stimulator" per GWJ. The legally marketed equivalence: The predicate marketed device is the Nihon Kohden MEB-2200A Neuropack per 510(k) #K991899,commercial distribution certification dated 9/1/1999. * A description of the device: The Neuromaster, MEE-1000A, Neur… | 1999 |
What descends from it? (10)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 19, 2012 | Class II | Z-0817-2016 | Device Design | The MEE-1000A Neuromaster had defective printed circuit boards (PCBs). Gas arrestors on these boards which were intended to provide protection from electrostatic discharge failed to prohibit unintentional current flow. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 1 company; a new generation was cleared every 6.0 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K142624 (Nihon Kohden Corporation, 2015) has gone furthest, with 8 descendants of its own.
- 1 other device also cites its predicate K991899.
How does its category compare?
All GWF devicesGWF Stimulator, Electrical, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Nihon Kohden's model number MEE-1000 is intended for medical purposes to measure, monitor, record and display the bioelectric signals produced by muscles (EMG), to stimulate peripheral nerves and to monitor, record and display the electrical activities produced by nerves to aid clinicians in the diagnosis and prognosis of neuromuscular disease. The device monitors electric/auditory/visual evoked potential, EEG and EMG. The device is also intended to…
Read the full statement (333 words)
Nihon Kohden's model number MEE-1000 is intended for medical purposes to measure, monitor, record and display the bioelectric signals produced by muscles (EMG), to stimulate peripheral nerves and to monitor, record and display the electrical activities produced by nerves to aid clinicians in the diagnosis and prognosis of neuromuscular disease. The device monitors electric/auditory/visual evoked potential, EEG and EMG. The device is also 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.
The device may use electrical stimulus, visual stimulus, or sound stimulus for use in evoked response measurements (EP). Continuous and/or periodic measurements of evoked potential activities are displayed and stored. The device applies an electrical stimulus to a patient thru 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. The device may be used to determine autonomic responses as psychological indicators by measuring the electrical resistance of the skin and the tissue path between two electrodes applied to the skin. 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).
The acquired waveforms are displayed in cascaded format and measurement data may be displayed on the trendgraph with waveforms annotations (events). The acquired waveforms with the measurement data can be saved in a large capacity storage media.
The device 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 device is available for use on any patient as determined by the medical professional including adults and children.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051178 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051178: Mee-1000A Neuromaster.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051178
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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