510(k) · Cleared
ClearedTwin Neurotrac-Iii
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Astro-Med, Inc. · OMA Amplitude-Integrated Electroencephalograph
Cleared on Dec 24, 2008 as substantially equivalent to K960170 (Moberg Medical, Inc., 1996) and 4 other predicates after a 204-day review. Its family tree reaches back 6 generations to 1996. 8 later devices descend from it.
- Decided
- Dec 24, 2008
- Review
- 204 days
- Class
- Class II
- Product code
- OMA
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K963644 (1996). 22 ancestors in all, the oldest K791580 (1979). 8 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK963644 A-1000 Eeg Monitor and a-1050 Eeg MonitorAspect Medical Systems, Inc. · 1996
- 5 generations backK973596 Spacelabs Medical 90482 Bispectral Index Analysis (Bis) ModuleSpacelabs Medical, Inc. · 1998
- 4 generations backK983229 Olympic Medical Lectromed Cerebral Function Monitor SystemOlympic Medical Corp. · 1999
- 3 generations backK030489 BRM2 Brain MonitorBrainz Instruments, Ltd. · 2003
- 2 generations backK033010 BRM2 Brain MonitorBrainz Instruments, Ltd. · 2003
- 1 generation backK071449 BRM3 Brain MonitorBrainz Instruments, Ltd. · 2007
- This deviceK081551 Twin Neurotrac-IiiAstro-Med, 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 · 3 generations on · 2 of its ownK213299 Wireless EEG SystemPascall Systems, Inc. · 2022
- Descendant · 4 generations on · 0 of its ownK254213 Pascall Sensor Unit (PSU1)Pascall Systems, Inc. · 2026
- Descendant · 4 generations on · 0 of its ownK240593 VEEGix EEG SystemNeuroServo, Inc. · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · 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
- K213299Wireless EEG SystemPascall Systems, Inc. · 2022 · 3 generations on2descendants
- K254213Pascall Sensor Unit (PSU1)Pascall Systems, Inc. · 2026 · 4 generations on0descendants
- K240593VEEGix EEG SystemNeuroServo, Inc. · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K963644 | A-1000 Eeg Monitor and a-1050 Eeg Monitor | Aspect Medical Systems, Inc. | 1996 | — |
| −5 | K973596 | Spacelabs Medical 90482 Bispectral Index Analysis (Bis) Module | Spacelabs Medical, Inc. | 1998 | — |
| −4 | K983229 | Olympic Medical Lectromed Cerebral Function Monitor System | Olympic Medical Corp. | 1999 | — |
| −3 | K030489 | BRM2 Brain Monitor | Brainz Instruments, Ltd. | 2003 | — |
| −2 | K033010 | BRM2 Brain Monitor | Brainz Instruments, Ltd. | 2003 | — |
| −1 | K071449 | BRM3 Brain Monitor | Brainz Instruments, Ltd. | 2007 | — |
| 0 (this device) | K081551 | Twin Neurotrac-Iii | Astro-Med, 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 | — |
| +3 | K213299 | Wireless EEG System | Pascall Systems, Inc. | 2022 | — |
| +4 | K254213 | Pascall Sensor Unit (PSU1) | Pascall Systems, Inc. | 2026 | — |
| +4 | K240593 | VEEGix EEG System | NeuroServo, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 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 |
| 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? (5)
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 |
|---|---|---|---|
| * | K960170 | Electroencephalograph (Eeg)Summary page 1…cephalograph Regulation Number: 882.1400 Product Code: * QM fx Product Class: ClahsAs i OLT, OkKT Substantial Equivalent Predicate Devices: » Neurotrac Il-EP, 510(k) #K960170, Moberg Medical, Inc., Purchased by Astro-Med, Inc. « Neurotrac Il, 510(k) # K914571, Moberg Medical, Inc., Purchased by Astro-M… | 1996 |
| * | K914571 | Neurotrac IISummary page 1…i OLT, OkKT Substantial Equivalent Predicate Devices: » Neurotrac Il-EP, 510(k) #K960170, Moberg Medical, Inc., Purchased by Astro-Med, Inc. « Neurotrac Il, 510(k) # K914571, Moberg Medical, Inc., Purchased by Astro-Med, Inc. o Nervus Monitor, 510(k) # K021185, Taugagreining HF, now Nicolet Biomedical… | 1992 |
| * | K021185 | Nervus MonitorSummary page 1…170, Moberg Medical, Inc., Purchased by Astro-Med, Inc. « Neurotrac Il, 510(k) # K914571, Moberg Medical, Inc., Purchased by Astro-Med, Inc. o Nervus Monitor, 510(k) # K021185, Taugagreining HF, now Nicolet Biomedical, a Viasys Healthcare/Cardinal Health Brand ¢ Olympic CFM6000, 510(k) # K031149, Olympi… | 2002 |
| * | K031149 | Olympic CFM 6000Summary page 1…by Astro-Med, Inc. o Nervus Monitor, 510(k) # K021185, Taugagreining HF, now Nicolet Biomedical, a Viasys Healthcare/Cardinal Health Brand ¢ Olympic CFM6000, 510(k) # K031149, Olympic Medical Corp, now a division of Natus Medical Inc. « BRM3 Brain Monitor, 510(k) #K071449, BrainZ instruments LTD., Auck… | 2003 |
| * | K071449 | BRM3 Brain MonitorSummary page 1…a Viasys Healthcare/Cardinal Health Brand ¢ Olympic CFM6000, 510(k) # K031149, Olympic Medical Corp, now a division of Natus Medical Inc. « BRM3 Brain Monitor, 510(k) #K071449, BrainZ instruments LTD., Auckland, New Zeland Device Description: TWin Neurotrac-lil is used with Grass-Technologies TWin (#K0… | 2007 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092573 | Nihon Kohden QP-160AK Eeg Trend Program | 2010 | 7 |
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 12 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 2 of the 22 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.
- 1 other device also cites its predicate K960170.
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?
To record the electroencephalogram (EEG) and the computed EEG trends over extended periods of time in order for trained health care professionals to observe changes over time. TWin Neurotrac-lll does not provide any diagnostic conclusion about the patient's condition.
TWin-Neurotrac-ill is intencied for use only by medically trained and qualified personnel, within a hospital or medical environment.
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/K081551 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081551: Twin Neurotrac-Iii.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081551
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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