510(k) · Cleared
ClearedNihon Kohden AE-918P Neuro Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nihon Kohden Corp. · OMA Amplitude-Integrated Electroencephalograph
Cleared on Mar 4, 2015 as substantially equivalent to K080546 (Nihon Kohden America, Inc., 2008) and 5 other predicates after a 762-day review. Its family tree reaches back 9 generations to 1988.
- Decided
- Mar 4, 2015
- Review
- 762 days
- Class
- Class II
- Product code
- OMA
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 9 generations to K875179 (1988). 79 ancestors in all, the oldest K791580 (1979). No later device cites it as a predicate yet.
- Root · 9 generations backK875179 Modified Laserflo Blood Perfusion Monitor, BPM403ATsi, Inc. · 1988
- 5 generations between
- 3 generations backK080217 Component Neuromonitoring SystemMoberg Research, Inc. · 2008 · Recalled
- 2 generations backK092573 Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc. · 2010
- 1 generation backK120485 Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa…Nihon Kohden America, Inc. · 2012
- This deviceK130238 Nihon Kohden AE-918P Neuro UnitNihon Kohden Corp. · 2015
Show all 9 generations
- Root · 9 generations backK875179 Modified Laserflo Blood Perfusion Monitor, BPM403ATsi, Inc. · 1988
- 8 generations backK951832 Laserflo Blood Perfusion Single Use Probes Models Sup-440, Supr-434…Vasamedics, LLC · 1996
- 7 generations backK961368 Trimflo Parenchymal Blood Flow Monitoring Probe KitVasamedics, LLC · 1996
- 6 generations backK013930 NeurosensorNovus Monitoring, Ltd. · 2002
- 5 generations backK050702 Neurosystems 1TM MonitorNeurosystems, LLC · 2005
- 4 generations backK061640 Integra Mobius Multi-Modality Monitoring SystemIntegra LifeSciences Corporation · 2006
- 3 generations backK080217 Component Neuromonitoring SystemMoberg Research, Inc. · 2008 · Recalled
- 2 generations backK092573 Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc. · 2010
- 1 generation backK120485 Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa…Nihon Kohden America, Inc. · 2012
- This deviceK130238 Nihon Kohden AE-918P Neuro UnitNihon Kohden Corp. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K875179 | Modified Laserflo Blood Perfusion Monitor, BPM403A | Tsi, Inc. | 1988 | — |
| −8 | K951832 | Laserflo Blood Perfusion Single Use Probes Models Sup-440, Supr-434 Sup-433 | Vasamedics, LLC | 1996 | — |
| −7 | K961368 | Trimflo Parenchymal Blood Flow Monitoring Probe Kit | Vasamedics, LLC | 1996 | — |
| −6 | K013930 | Neurosensor | Novus Monitoring, Ltd. | 2002 | — |
| −5 | K050702 | Neurosystems 1TM Monitor | Neurosystems, LLC | 2005 | — |
| −4 | K061640 | Integra Mobius Multi-Modality Monitoring System | Integra LifeSciences Corporation | 2006 | — |
| −3 | K080217 | Component Neuromonitoring System | Moberg Research, Inc. | 2008 | 1 |
| −2 | K092573 | Nihon Kohden QP-160AK Eeg Trend Program | Nihon Kohden America, Inc. | 2010 | — |
| −1 | K120485 | Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend… | Nihon Kohden America, Inc. | 2012 | — |
| 0 (this device) | K130238 | Nihon Kohden AE-918P Neuro Unit | Nihon Kohden Corp. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 4 | 0 |
| 1986 | 3 | 0 |
| 1987 | 3 | 0 |
| 1988 | 1 | 0 |
| 1989 | 3 | 0 |
| 1990 | 1 | 0 |
| 1991 | 5 | 0 |
| 1992 | 4 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 6 | 0 |
| 1999 | 5 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2013 | 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 OMA? 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 OMA device
- #1 K192889 Neoscore -1.2 · 1 generation · no Class I recall
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K080546 | Nihon Kohden Eeg-1200A Series Neurofax, Model Eeg-1200ASummary page 4…400 Classification: Class II Product Code: OMC Panel: Neurological Predicate Device: EEG-1200A Series Neurofax K080546 Nihon Kohden AE-918P Neuro Unit Section 5 – Page 1 of 5 === Page… | 2008 |
| * | K051178 | Mee-1000A NeuromasterSummary page 5…onality in this system (Table 1). Table 1 K# Product Manufacturer Aspect K051178 MEE-1000 Nihon Kohden MDF function K963644 A-1050… | 2005 |
| * | K963644 | A-1000 Eeg Monitor and a-1050 Eeg MonitorSummary page 5…K# Product Manufacturer Aspect K051178 MEE-1000 Nihon Kohden MDF function K963644 A-1050 Aspect MDF function K021185 Nervus Monitor… | 1996 |
| * | K021185 | Nervus MonitorSummary page 5…178 MEE-1000 Nihon Kohden MDF function K963644 A-1050 Aspect MDF function K021185 Nervus Monitor Nervus Total Power K120485 QP-160AK Niho… | 2002 |
| * | K120485 | Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT PSummary page 5…644 A-1050 Aspect MDF function K021185 Nervus Monitor Nervus Total Power K120485 QP-160AK Nihon Kohden aEEG K131789 Celebralogik Men… | 2012 |
| * | K131789 | Cerebralogik- Aeeg Cleared while this submission was under review Summary page 5…K021185 Nervus Monitor Nervus Total Power K120485 QP-160AK Nihon Kohden aEEG K131789 Celebralogik Mennen aEEG Product Description: Electroencephalography (EEG) is… | 2013 |
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 27 years and passes through 8 companies; a new generation was cleared every 2.3 years on median.
- 11 of the 79 ancestors have a recall of any class.
- 4 other devices also cite its predicate K080546.
How does its category compare?
All OMA devicesOMA Amplitude-Integrated Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · OMA
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · OMA
Too few OMA 510(k)s in any year since 2007 to give a median.
Recalls per year · OMA
No recall names OMA since 2007.
Adverse event reports per year · OMA
2in 2024
MAUDE reports naming product code OMA, 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 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AE-918P EEG Neuro Unit is an 8 channel EEG measuring unit that connects to a Nihon Kohden patient monitor and is intended to monitor brain function. The unit amplifies and analyzes EEG and displays the EEG waveform and the result of analysis on the patient monitor. The AE-918P EEG Neuro Unit includes the calculation of a set of quantitative measures intended to monitor and analyze the EEG waveform. These include quantitative EEG functions such as…
Read the full statement (164 words)
The AE-918P EEG Neuro Unit is an 8 channel EEG measuring unit that connects to a Nihon Kohden patient monitor and is intended to monitor brain function. The unit amplifies and analyzes EEG and displays the EEG waveform and the result of analysis on the patient monitor.
The AE-918P EEG Neuro Unit includes the calculation of a set of quantitative measures intended to monitor and analyze the EEG waveform. These include quantitative EEG functions such as SEF, MDF, PPF, TP, CSA, DSA, %Delta, %Theta, %Alpha, %Beta, %Gamma, Abs Delta, Abs Theta, Abs Alpha, Abs Beta, and Abs Gamma. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG waveform. The aEEG functionality included in the AE-918P EEG Neuro Unit is intended to monitor the state of the brain.
The device is intended for use by medical personnel in any location within a medical facility, physician’s office, laboratory, clinic or nursing home under direct supervision of a medical professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130238 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130238: Nihon Kohden AE-918P Neuro Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130238
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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