510(k) · Cleared
ClearedNeuroMatch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
LVIS Corporation · OLX Source Localization Software For Electroencephalograph Or Magnetoencephalograph
Cleared on May 23, 2025 as substantially equivalent to K172858 (Epilog, 2018) after a 116-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- May 23, 2025
- Review
- 116 days
- Class
- Class II
- Product code
- OLX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K002631 (2000). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002631 | Electroencephalograph Software Eemagine Eeg | Eemagine Medical Imaging Solutions GmbH | 2000 | — |
| −2 | K092844 | Geosource | Electrical Geodesics, Inc. | 2010 | — |
| −1 | K172858 | PreOp | Epilog | 2018 | — |
| 0 (this device) | K250239 | NeuroMatch | LVIS Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 OLX? 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 OLX device
- #1 K260563 CN-Suite™score 14.0 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K172858 | PreOpSummary page 6…aph Classification Name: Electroencephalograph (21CFR 882.1400) Device Class: II Product Code: OMB, OLT, OMA,OLX Predicate Device: Epilog PreOp, K172858 Reference Device: Neurosoft CURRY Multimodal Neuroimaging Software, K001781 Date Prepared: January 24, 2025 Device Description… | 2018 |
| † | K001781 | Curry Multimodal Neuroimaging Software | 2001 |
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 25 years and passes through 4 companies; a new generation was cleared every 7.4 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K172858.
How does its category compare?
All OLX devicesOLX Source Localization Software For Electroencephalograph Or Magnetoencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · OLX
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLX
462in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLX
No recall names OLX since 2007.
Adverse event reports per year · OLX
1in 2015
MAUDE reports naming product code OLX, 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 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 3 | 462 | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
1. LVIS NeuroMatch Software is intended for the review, monitoring and analysis of electroencephalogram (EEG) recordings made by EEG devices using scalp electrodes and to aid neurologists in the assessment of EEG. The device is intended to be used by qualified medical practitioners who will exercise professional judgement in using the information. 2. The Seizure Detection component of LVIS NeuroMatch is intended to mark previously acquired sections of…
Read the full statement (387 words)
1. LVIS NeuroMatch Software is intended for the review, monitoring and analysis of electroencephalogram (EEG) recordings made by EEG devices using scalp electrodes and to aid neurologists in the assessment of EEG. The device is intended to be used by qualified medical practitioners who will exercise professional judgement in using the information.
2. The Seizure Detection component of LVIS NeuroMatch is intended to mark previously acquired sections of adult EEG recordings from patients greater than or equal to 18 years old that may correspond to electrographic seizures, in order to assist qualified medical practitioners in the assessment of EEG traces. EEG recordings should be obtained with a full scalp montage according to the electrodes from the International Standard 10-20 placement.
3. The Spike Detection component of LVIS NeuroMatch is intended to mark previously acquired sections of adult EEG recordings from patients ≥18 years old that may correspond to spikes, in order to assist qualified medical practitioners in the assessment of EEG traces. LVIS NeuroMatch Spike Detection performance has not been assessed for intracranial recordings.
4. LVIS NeuroMatch includes the calculation and display of a set of quantitative measures intended to monitor and analyze EEG waveforms. These include Artifact Strength, Asymmetry Spectrogram, Autocorrelation Spectrogram, and Fast Fourier Transform (FFT) Spectrogram. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG waveforms.
5. LVIS NeuroMatch displays physiological signals such as electrocardiogram (ECG/EKG) if it is provided in the EEG recording.
6. The aEEG functionality included in LVIS NeuroMatch is intended to monitor the state of the brain.
7. LVIS NeuroMatch Artifact Reduction (AR) is intended to reduce muscle and eye movements, in EEG signals from the International Standard 10-20 placement. AR does not remove the entire artifact signal and is not effective for other types of artifacts. AR may modify portions of waveforms representing cerebral activity. Waveforms must still be read by a qualified medical practitioner trained in recognizing artifacts, and any interpretation or diagnosis must be made with reference to the original waveforms.
8. LVIS NeuroMatch EEG source localization visualizes brain electrical activity on a 3D idealized head model. LVIS NeuroMatch source localization additionally calculates and displays summary trends based on source localization findings over time.
9. This device does not provide any diagnostic conclusion about the patient’s condition to the user.
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/K250239 · printed Nov 3, 2026
Cite this page
510(k) Report. “K250239: NeuroMatch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K250239
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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