510(k) · Cleared
Recalled · Class II · 2023Component Neuromonitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Moberg Research, Inc. · OMA Amplitude-Integrated Electroencephalograph
Cleared on Nov 5, 2008 as substantially equivalent to K974496 (Aspect Medical Systems, Inc., 1998) and 8 other predicates after a 281-day review. Its family tree reaches back 6 generations to 1988. 14 later devices descend from it. It has been recalled once.
- Decided
- Nov 5, 2008
- Review
- 281 days
- Class
- Class II
- Product code
- OMA
- Recalls
- 1
- Predicates
- 9
Its longest line of descent runs back 6 generations to K875179 (1988). 44 ancestors in all, the oldest K791580 (1979). 14 later devices descend from it, 5 citing it directly.
- Root · 6 generations backK875179 Modified Laserflo Blood Perfusion Monitor, BPM403ATsi, Inc. · 1988
- 5 generations backK951832 Laserflo Blood Perfusion Single Use Probes Models Sup-440, Supr-434…Vasamedics, LLC · 1996
- 4 generations backK961368 Trimflo Parenchymal Blood Flow Monitoring Probe KitVasamedics, LLC · 1996
- 3 generations backK013930 NeurosensorNovus Monitoring, Ltd. · 2002
- 2 generations backK050702 Neurosystems 1TM MonitorNeurosystems, LLC · 2005
- 1 generation backK061640 Integra Mobius Multi-Modality Monitoring SystemIntegra LifeSciences Corporation · 2006
- This deviceK080217 Component Neuromonitoring SystemMoberg Research, Inc. · 2008
- Descendant · cites it directly · 7 of its ownK092573 Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc. · 2010
- Descendant · 2 generations on · 5 of its ownK120485 Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa…Nihon Kohden America, Inc. · 2012
- Descendant · cites it directly · 3 of its ownK173366 NicoletOneNatus Neurology Incorporated · 2018
- Descendant · 3 generations on · 2 of its ownK213299 Wireless EEG SystemPascall Systems, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK200878 Natus NeuroWorksNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · 2020
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K092573Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc. · 2010 · cites it directly7descendants
- K120485Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT PNihon Kohden America, Inc. · 2012 · 2 generations on5descendants
- K173366NicoletOneNatus Neurology Incorporated · 2018 · cites it directly3descendants
- K213299Wireless EEG SystemPascall Systems, Inc. · 2022 · 3 generations on2descendants
- K200878Natus NeuroWorksNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · 2020 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K875179 | Modified Laserflo Blood Perfusion Monitor, BPM403A | Tsi, Inc. | 1988 | — |
| −5 | K951832 | Laserflo Blood Perfusion Single Use Probes Models Sup-440, Supr-434 Sup-433 | Vasamedics, LLC | 1996 | — |
| −4 | K961368 | Trimflo Parenchymal Blood Flow Monitoring Probe Kit | Vasamedics, LLC | 1996 | — |
| −3 | K013930 | Neurosensor | Novus Monitoring, Ltd. | 2002 | — |
| −2 | K050702 | Neurosystems 1TM Monitor | Neurosystems, LLC | 2005 | — |
| −1 | K061640 | Integra Mobius Multi-Modality Monitoring System | Integra LifeSciences Corporation | 2006 | — |
| 0 (this device) | K080217 | Component Neuromonitoring System | Moberg Research, Inc. | 2008 | — |
| +1 | K092573 | Nihon Kohden QP-160AK Eeg Trend Program | Nihon Kohden America, Inc. | 2010 | — |
| +2 | K120485 | Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend… | Nihon Kohden America, Inc. | 2012 | — |
| +1 | K173366 | NicoletOne | Natus Neurology Incorporated | 2018 | — |
| +3 | K213299 | Wireless EEG System | Pascall Systems, Inc. | 2022 | — |
| +1 | K200878 | Natus NeuroWorks | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 4 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (9)
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 |
|---|---|---|---|
| * | K974496 | A-2000 Eeg Monitor with BisSummary page 1…Code: GWQ) Date of Preparation: September 22, 2008 Substantially Equivalent Devices: Product Name 510(k) Number | Manufacturer / Submitter A-2000 EEG Monitor with BIS k974496 Aspect Medical Bravo Multi-Modality System k991054 Nicolet Biomedical BRM2 Brain Monitor K033010 BrainZ Instruments CFM 6000 . k… | 1998 |
| * | K991054 | Bravo Multi-Modality SystemSummary page 1…Substantially Equivalent Devices: Product Name 510(k) Number | Manufacturer / Submitter A-2000 EEG Monitor with BIS k974496 Aspect Medical Bravo Multi-Modality System k991054 Nicolet Biomedical BRM2 Brain Monitor K033010 BrainZ Instruments CFM 6000 . k031149 Olympic Medical HARMONIE-Schwarzer EEG System… | 1999 |
| * | K033010 | BRM2 Brain MonitorSummary page 1…me 510(k) Number | Manufacturer / Submitter A-2000 EEG Monitor with BIS k974496 Aspect Medical Bravo Multi-Modality System k991054 Nicolet Biomedical BRM2 Brain Monitor K033010 BrainZ Instruments CFM 6000 . k031149 Olympic Medical HARMONIE-Schwarzer EEG System | k010728 Stellate Systems Integra Mobius Mui… | 2003 |
| * | K031149 | Olympic CFM 6000Summary page 1…itter A-2000 EEG Monitor with BIS k974496 Aspect Medical Bravo Multi-Modality System k991054 Nicolet Biomedical BRM2 Brain Monitor K033010 BrainZ Instruments CFM 6000 . k031149 Olympic Medical HARMONIE-Schwarzer EEG System | k010728 Stellate Systems Integra Mobius Muiti-Modality System | k061640 Integra N… | 2003 |
| * | K010728 | Harmone-Schwarzer Eeg SystemSummary page 1…Bravo Multi-Modality System k991054 Nicolet Biomedical BRM2 Brain Monitor K033010 BrainZ Instruments CFM 6000 . k031149 Olympic Medical HARMONIE-Schwarzer EEG System | k010728 Stellate Systems Integra Mobius Muiti-Modality System | k061640 Integra NeuroSciences Nervus Monitor k021185 Taugagreining HF Neu… | 2001 |
| * | K061640 | Integra Mobius Multi-Modality Monitoring SystemSummary page 1…ain Monitor K033010 BrainZ Instruments CFM 6000 . k031149 Olympic Medical HARMONIE-Schwarzer EEG System | k010728 Stellate Systems Integra Mobius Muiti-Modality System | k061640 Integra NeuroSciences Nervus Monitor k021185 Taugagreining HF Neurotrac II-EP k960170 Moberg Medical Lectromed Cerebral Function… | 2006 |
| * | K021185 | Nervus MonitorSummary page 1…00 . k031149 Olympic Medical HARMONIE-Schwarzer EEG System | k010728 Stellate Systems Integra Mobius Muiti-Modality System | k061640 Integra NeuroSciences Nervus Monitor k021185 Taugagreining HF Neurotrac II-EP k960170 Moberg Medical Lectromed Cerebral Function Monitor | k983229 Olympic Medical System Ind… | 2002 |
| * | K960170 | Electroencephalograph (Eeg)Summary page 1…warzer EEG System | k010728 Stellate Systems Integra Mobius Muiti-Modality System | k061640 Integra NeuroSciences Nervus Monitor k021185 Taugagreining HF Neurotrac II-EP k960170 Moberg Medical Lectromed Cerebral Function Monitor | k983229 Olympic Medical System Indications for Use: The Component Neuromon… | 1996 |
| * | K983229 | Olympic Medical Lectromed Cerebral Function Monitor SystemSummary page 1…uiti-Modality System | k061640 Integra NeuroSciences Nervus Monitor k021185 Taugagreining HF Neurotrac II-EP k960170 Moberg Medical Lectromed Cerebral Function Monitor | k983229 Olympic Medical System Indications for Use: The Component Neuromonitoring System™ is intended to monitor the state of the brain… | 1999 |
What descends from it? (14)
See all 145 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 |
|---|---|---|---|---|
| Feb 20, 2023 | Class II | Z-1338-2023 | Under Investigation by firm | Battery leakage can cause corrosion to the metal enclosure near the electrical interface. Prolonged contact to corrosive materials could cause injury to skin. DOC |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 6 companies; a new generation was cleared every 3.2 years on median.
- 8 of the 44 ancestors have a recall of any class.
- Of its descendants, K092573 (Nihon Kohden America, Inc., 2010) has gone furthest, with 7 descendants of its own.
- 5 other devices also cite its predicate K974496.
How does its category compare?
All OMA devicesOMA Amplitude-Integrated Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Component Neuromonitoring System™ is intended to monitor the state of the brain by recording and displaying EEG signals, and can also receive and display a variety of vital signs and other measurements from third-party monitoring devices (such as ICP, ECG, SpO,, and others). It also has the optional capability to record and display patient video.
The Component Neuromonitoring System is intended for use by a physician or other qualified medical personnel. It is intended for use on patients of all ages within a hospital or medical environment, including the operating room, intensive care unit, emergency room, and clinical research settings.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K080217 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080217: Component Neuromonitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080217
Report an extraction error
Are you the manufacturer?
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