510(k) · Cleared
ClearedNihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT P
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nihon Kohden America, Inc. · OMA Amplitude-Integrated Electroencephalograph
Cleared on Mar 16, 2012 as substantially equivalent to K092573 (Nihon Kohden America, Inc., 2010) and 2 other predicates after a 28-day review. Its family tree reaches back 8 generations to 1988. 5 later devices descend from it.
- Decided
- Mar 16, 2012
- Review
- 28 days
- Class
- Class II
- Product code
- OMA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K875179 (1988). 71 ancestors in all, the oldest K791580 (1979). 5 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK875179 Modified Laserflo Blood Perfusion Monitor, BPM403ATsi, Inc. · 1988
- 7 generations backK951832 Laserflo Blood Perfusion Single Use Probes Models Sup-440, Supr-434…Vasamedics, LLC · 1996
- 6 generations backK961368 Trimflo Parenchymal Blood Flow Monitoring Probe KitVasamedics, LLC · 1996
- 5 generations backK013930 NeurosensorNovus Monitoring, Ltd. · 2002
- 4 generations backK050702 Neurosystems 1TM MonitorNeurosystems, LLC · 2005
- 3 generations backK061640 Integra Mobius Multi-Modality Monitoring SystemIntegra LifeSciences Corporation · 2006
- 2 generations backK080217 Component Neuromonitoring SystemMoberg Research, Inc. · 2008 · Recalled
- 1 generation backK092573 Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc. · 2010
- This deviceK120485 Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa…Nihon Kohden America, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK213299 Wireless EEG SystemPascall Systems, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK254213 Pascall Sensor Unit (PSU1)Pascall Systems, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK240593 VEEGix EEG SystemNeuroServo, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK163644 Nihon Kohden QP-160AK EEG Trend ProgramNihon Kohden Corporation · 2017
- Descendant · cites it directly · 0 of its ownK130238 Nihon Kohden AE-918P Neuro UnitNihon Kohden Corp. · 2015
Most influential descendants
Showing 5 of 5 · See all- K213299Wireless EEG SystemPascall Systems, Inc. · 2022 · cites it directly2descendants
- K254213Pascall Sensor Unit (PSU1)Pascall Systems, Inc. · 2026 · 2 generations on0descendants
- K240593VEEGix EEG SystemNeuroServo, Inc. · 2024 · 2 generations on0descendants
- K163644Nihon Kohden QP-160AK EEG Trend ProgramNihon Kohden Corporation · 2017 · cites it directly0descendants
- K130238Nihon Kohden AE-918P Neuro UnitNihon Kohden Corp. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K875179 | Modified Laserflo Blood Perfusion Monitor, BPM403A | Tsi, Inc. | 1988 | — |
| −7 | K951832 | Laserflo Blood Perfusion Single Use Probes Models Sup-440, Supr-434 Sup-433 | Vasamedics, LLC | 1996 | — |
| −6 | K961368 | Trimflo Parenchymal Blood Flow Monitoring Probe Kit | Vasamedics, LLC | 1996 | — |
| −5 | K013930 | Neurosensor | Novus Monitoring, Ltd. | 2002 | — |
| −4 | K050702 | Neurosystems 1TM Monitor | Neurosystems, LLC | 2005 | — |
| −3 | K061640 | Integra Mobius Multi-Modality Monitoring System | Integra LifeSciences Corporation | 2006 | — |
| −2 | K080217 | Component Neuromonitoring System | Moberg Research, Inc. | 2008 | 1 |
| −1 | K092573 | Nihon Kohden QP-160AK Eeg Trend Program | Nihon Kohden America, Inc. | 2010 | — |
| 0 (this device) | K120485 | Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend… | Nihon Kohden America, Inc. | 2012 | — |
| +1 | K213299 | Wireless EEG System | Pascall Systems, Inc. | 2022 | — |
| +2 | K254213 | Pascall Sensor Unit (PSU1) | Pascall Systems, Inc. | 2026 | — |
| +2 | K240593 | VEEGix EEG System | NeuroServo, Inc. | 2024 | — |
| +1 | K163644 | Nihon Kohden QP-160AK EEG Trend Program | Nihon Kohden Corporation | 2017 | — |
| +1 | 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 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 6 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 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 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? (3)
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 |
|---|---|---|---|
| * | K092573 | Nihon Kohden QP-160AK Eeg Trend ProgramSummary page 1…Name: Nihon Kohden QP-1 6OAK EEG Trend Program Common or usual Name: Electroencephalograph (EEG) Legally Marketed Predicate: Nihon Kobden QP-1 6OAK EEG Trend Program (K092573) Applied Neuroscience NeuroGuide Analysis System (K041 263) Brain Scope Zoom- IOODC (K082886) Intended Use: The QP-1I60AK Tren… | 2010 |
| * | K041263 | Neuroguide Analysis SystemSummary page 1…sual Name: Electroencephalograph (EEG) Legally Marketed Predicate: Nihon Kobden QP-1 6OAK EEG Trend Program (K092573) Applied Neuroscience NeuroGuide Analysis System (K041 263) Brain Scope Zoom- IOODC (K082886) Intended Use: The QP-1I60AK Trend program is a software-only device intended to be installed… | 2004 |
| * | K082886 | Zoom-100DCSummary page 1…G) Legally Marketed Predicate: Nihon Kobden QP-1 6OAK EEG Trend Program (K092573) Applied Neuroscience NeuroGuide Analysis System (K041 263) Brain Scope Zoom- IOODC (K082886) Intended Use: The QP-1I60AK Trend program is a software-only device intended to be installed on the EEG- 1200A series electroen… | 2009 |
What descends from it? (5)
3 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)
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 24 years and passes through 7 companies; a new generation was cleared every 2.3 years on median.
- 9 of the 71 ancestors have a recall of any class.
- Of its descendants, K213299 (Pascall Systems, Inc., 2022) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K092573.
How does its category compare?
All OMA devicesOMA Amplitude-Integrated Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 QP- I60AK Trend program is a software-only device intended to be installed on the EEG-1I200A series electroencephalograph to record, calculate, and display EEG data obtained from the EEG-1 200A system. This device is intended to be used by qualified medical practitioners, trained in Electroencephalography, who will exercise professional judgment when using the information. The intended use for each of the software's outputs is as follows: * The EEG…
Read the full statement (187 words)
The QP- I60AK Trend program is a software-only device intended to be installed on the EEG-1I200A series electroencephalograph to record, calculate, and display EEG data obtained from the EEG-1 200A system. This device is intended to be used by qualified medical practitioners, trained in Electroencephalography, who will exercise professional judgment when using the information.
The intended use for each of the software's outputs is as follows:
* The EEG and aEEG waveforms are intended to help the user monitor the state of the brain.
* The user-defined Fast Fourier Transform (FFT) parameters of this software (FFT power) are intended to help the user analyze the EEG waveform.
* The burst suppression parameters of this software (interburst interval and bursts per minute) are intended to aid in the identification and characterization of areas of burst-suppression pattern in the EEG.
This device does not provide any diagnostic conclusion about the patient's condition to the user.
The device is intended for use by medical personnel in any location within a medical facility, laboratory, clinic or nursing home or outside of a medical facility under direct supervision of a medical professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120485 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120485: Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120485
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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