510(k) · Cleared
ClearedMeb-2300A Neuropack Evoked Potential and Emg Measuring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nihon Kohden Corp. · GWF Stimulator, Electrical, Evoked Response
Cleared on Sep 19, 2012 as substantially equivalent to K991899 (Nihon Kohden America, Inc., 1999) after a 224-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it.
- Decided
- Sep 19, 2012
- Review
- 224 days
- Class
- Class II
- Product code
- GWF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K950208 (1995). 1 later device descends from it, 1 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 deviceK120397 Meb-2300A Neuropack Evoked Potential and Emg Measuring SystemNihon Kohden Corp. · 2012
- Descendant · cites it directly · 0 of its ownK191700 EyeStatBlinktbi, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K191700EyeStatBlinktbi, Inc. · 2019 · cites it directly0descendants
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) | K120397 | Meb-2300A Neuropack Evoked Potential and Emg Measuring System | Nihon Kohden Corp. | 2012 | — |
| +1 | K191700 | EyeStat | Blinktbi, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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…, Electrical, Evoked Response 882.1870 GWI Predicate Device(s): MEB-2200A Neuropack Evoked Potential and K991899 EMG Measuring System 1.0 Description of Device Tbe MEB-2200A Neuropack Evoked Potential and EMO Measuri… | 1999 |
| † | K031510 | Nim-Spine | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191700 | EyeStat | 2019 | 0 |
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 17 years and passes through 2 companies; a new generation was cleared every 13.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K191700 (Blinktbi, Inc., 2019) has gone furthest, with 0 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. 2012, 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 Nihon Kohden MEB-2300A Neuropack Evoked Potential and EMG Measuring System is intended to monitor, record and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor, record and display the electrical activity produced by nerves to aid the clinician in the diagnosis and prognosis of neuromuscular disease (EMG). The device is also intended to measure and display nerve conduction time by applying a stimulus…
Read the full statement (215 words)
The Nihon Kohden MEB-2300A Neuropack Evoked Potential and EMG Measuring System is intended to monitor, record and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor, record and display the electrical activity produced by nerves to aid the clinician in the diagnosis and prognosis of neuromuscular disease (EMG). The device is also intended to measure and display nerve conduction time by applying a stimulus to a patient's nerve (NCV). The device may use electrical stimulus, visual stimulus, or sound stimulus for use in evoked response measurements (EP). 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 activity of the patient's brain obtained by placing two or more electrodes on the head (EEG).
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 may also be placed in the intensive care unit or operating room for continuous recording.
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/K120397 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120397: Meb-2300A Neuropack Evoked Potential and Emg Measuring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120397
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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