510(k) · Cleared
ClearedNihon Kohden QP-160AK EEG Trend Program
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nihon Kohden Corporation · OMA Amplitude-Integrated Electroencephalograph
Cleared on May 19, 2017 as substantially equivalent to K120485 (Nihon Kohden America, Inc., 2012) and 1 other predicate after a 147-day review. Its family tree reaches back 9 generations to 1988.
- Decided
- May 19, 2017
- Review
- 147 days
- Class
- Class II
- Product code
- OMA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K875179 (1988). 73 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 deviceK163644 Nihon Kohden QP-160AK EEG Trend ProgramNihon Kohden Corporation · 2017
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 deviceK163644 Nihon Kohden QP-160AK EEG Trend ProgramNihon Kohden Corporation · 2017
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) | K163644 | Nihon Kohden QP-160AK EEG Trend Program | Nihon Kohden Corporation | 2017 | — |
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 |
| 2014 | 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? (2)
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 |
|---|---|---|---|
| * | K120485 | Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT PSummary page 4…rimary product OMB, OLT, ORT, OMA codes: Regulation numbers: 21 CFR 882.1400 Substantial equivalence claimed to: Nihon Kohden QP-160AK EEG Trend Program (K120485) Persyst 12 EEG Review and Analysis Software (K133793) Description: The QP-160AK EEG Tr… | 2012 |
| * | K133793 | Persyst 12 ( P12) Egg Review and Analysis SoftwareSummary page 4…stantial equivalence claimed to: Nihon Kohden QP-160AK EEG Trend Program (K120485) Persyst 12 EEG Review and Analysis Software (K133793) Description: The QP-160AK EEG Trend Program is a software-only device. When installed in Nihon Kohden neurology products with… | 2014 |
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 29 years and passes through 8 companies; a new generation was cleared every 2.3 years on median.
- 9 of the 73 ancestors have a recall of any class.
- 2 other devices also cite its predicate K120485.
How does its category compare?
All OMA devicesOMA Amplitude-Integrated Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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-160AK EEG Trend Program is a software-only device intended to calculate and display EEG data obtained from the Nihon Kohden specified host device. The QP-160AK is intended to be used by qualified medical practitioners, trained in electroencephalography, who will exercise professional judgment when using the information. The intended use is as follows: • The EEG and aEEG waveforms are intended to help the user monitor the state of the brain. • The…
Read the full statement (263 words)
The QP-160AK EEG Trend Program is a software-only device intended to calculate and display EEG data obtained from the Nihon Kohden specified host device. The QP-160AK is intended to be used by qualified medical practitioners, trained in electroencephalography, who will exercise professional judgment when using the information.
The intended use 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.
• The seizure detection component of QP-160AK is intended to mark previously acquired EEG waveforms of adult (greater than or equal to 18 years) that may correspond to electrographic seizures in order to aid in identification of seizure events and help review and annotation of EEG traces by user. EEG should be recorded with full scalp montage at the standard 10/20 system. The notifications for seizure detection are provided. QP-160AK notifications cannot be used as a substitute for real time monitoring of the underlying EEG by a trained expert.
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/K163644 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163644: Nihon Kohden QP-160AK EEG Trend Program.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163644
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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