510(k) · Cleared
ClearedIdentevent, Version 1.0G
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optima Neuroscience, Inc. · OMB Automatic Event Detection Software For Full-Montage Electroencephalograph
Cleared on Oct 16, 2009 as substantially equivalent to K011397 (Persyst Development Corp., 2001) and 1 other predicate after a 102-day review. Its family tree reaches back 3 generations to 1980. 9 later devices descend from it.
- Decided
- Oct 16, 2009
- Review
- 102 days
- Class
- Class II
- Product code
- OMB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K801604 (1980). 17 ancestors in all. 9 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK801604 Pathfinder Electrodiagnostic SystemNicolet Biomedical Instruments · 1980
- 2 generations backK974748 Neurometric Analysis SystemNxlink, Ltd. · 1998
- 1 generation backK041263 Neuroguide Analysis SystemApplied Neuroscience, Inc. · 2004
- This deviceK092039 Identevent, Version 1.0GOptima Neuroscience, Inc. · 2009
- 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 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · 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 |
|---|---|---|---|---|---|
| −3 | K801604 | Pathfinder Electrodiagnostic System | Nicolet Biomedical Instruments | 1980 | — |
| −2 | K974748 | Neurometric Analysis System | Nxlink, Ltd. | 1998 | — |
| −1 | K041263 | Neuroguide Analysis System | Applied Neuroscience, Inc. | 2004 | — |
| 0 (this device) | K092039 | Identevent, Version 1.0G | Optima Neuroscience, Inc. | 2009 | — |
| +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 |
|---|---|---|
| 1985 | 3 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1991 | 3 | 0 |
| 1995 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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 OMB? 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 OMB device
- #1 K240993 encevis (2.1)score 15.0 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K011397 | Persyst RevealSummary page 1…Electroencephalogram (EEG) signal spectrum analyzer Classification Code: OMB, OLT Regulatory Class: 11 Predicate Devices: Persyst Reveal® (K01 1397) NeuroGuide Analysis System (K041263) Description: Optima's IdentEventTM analyzes digital scalp ele… | 2001 |
| * | K041263 | Neuroguide Analysis SystemSummary page 1…analyzer Classification Code: OMB, OLT Regulatory Class: 11 Predicate Devices: Persyst Reveal® (K01 1397) NeuroGuide Analysis System (K041263) Description: Optima's IdentEventTM analyzes digital scalp electroencephalograph (EEG) signals reco… | 2004 |
What descends from it? (9)
2 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 29 years and passes through 4 companies; a new generation was cleared every 6.1 years on median.
- None of the 17 ancestors has a recall.
- Of its descendants, K092573 (Nihon Kohden America, Inc., 2010) has gone furthest, with 7 descendants of its own.
- 3 other devices also cite its predicate K011397.
How does its category compare?
All OMB devicesOMB Automatic Event Detection Software For Full-Montage Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · OMB
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OMB
143in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OMB
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OMB
6in 2025
MAUDE reports naming product code OMB, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 2 |
| 2015 | 3 | 233 | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 3 | 108 | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 1 | 0 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 4 |
| 2024 | 5 | 201 | 0 | 21 |
| 2025 | 5 | 143 | 0 | 6 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
IdentEventTM is a software-only product with an algorithm intended to analyze previously acquired, adult (>18 years) scalp EEG signals and mark events that may correspond to electrographic seizures for the purpose of reviewing prolonged EEG traces. The marked events are reviewed, possibly deleted, and interpreted by qualified clinical practitioners who will exercise professional judgment in using the information. IdentEvent also includes the display of…
Read the full statement (124 words)
IdentEventTM is a software-only product with an algorithm intended to analyze previously acquired, adult (>18 years) scalp EEG signals and mark events that may correspond to electrographic seizures for the purpose of reviewing prolonged EEG traces. The marked events are reviewed, possibly deleted, and interpreted by qualified clinical practitioners who will exercise professional judgment in using the information.
IdentEvent also includes the display of the quantitative EEG parameters Amplitude Variation and Maximum Frequency, which are intended to help the user analyze the EEG waveform after it has been collected.
IdentEvent requires the use of EEGs recorded with at least a 16-channel scalp montage following the standard 10/20 electrode placement system. IdentEvent does not provide any diagnostic conclusion about the patient's condition to the user.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092039 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092039: Identevent, Version 1.0G.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092039
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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