510(k) · Cleared
ClearedautoSCORE (V 2.0.0)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Holberg Eeg AS · OMB Automatic Event Detection Software For Full-Montage Electroencephalograph
Cleared on Apr 9, 2025 as substantially equivalent to K171720 (Ait Austrian Institute of Technology GmbH, 2018) and 1 other predicate after a 126-day review. Its family tree reaches back 3 generations to 2013. 1 later device descends from it.
- Decided
- Apr 9, 2025
- Review
- 126 days
- Class
- Class II
- Product code
- OMB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K132306 (2013). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK132306 Persyst 12 Eeg Review and Analysis SoftwarePersyst Development Corp. · 2013
- 2 generations backK171720 encevisAit Austrian Institute of Technology GmbH · 2018
- 1 generation backK231068 autoSCOREHolberg Eeg AS · 2024
- This deviceK243743 autoSCORE (V 2.0.0)Holberg Eeg AS · 2025
- Descendant · cites it directly · 0 of its ownK260998 Ceribell Neurology Review SoftwareCeribell, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K260998Ceribell Neurology Review SoftwareCeribell, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K132306 | Persyst 12 Eeg Review and Analysis Software | Persyst Development Corp. | 2013 | — |
| −2 | K171720 | encevis | Ait Austrian Institute of Technology GmbH | 2018 | — |
| −1 | K231068 | autoSCORE | Holberg Eeg AS | 2024 | — |
| 0 (this device) | K243743 | autoSCORE (V 2.0.0) | Holberg Eeg AS | 2025 | — |
| +1 | K260998 | Ceribell Neurology Review Software | Ceribell, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K171720 | encevisSummary page 5…redicate Device Trade/Device Name: encevis Model Number: 1.6 510(K) Submitter/Holder: AIT Austrian Institute of Technology GmbH 510(K) Reference: K171720 4.2 Additional Predicate Device Trade/Device Name: autoSCORE Model Number: autoSCORE V1.4 510(K) Submitte… | 2018 |
| * | K231068 | autoSCORESummary page 5…2 Additional Predicate Device Trade/Device Name: autoSCORE Model Number: autoSCORE V1.4 510(K) Submitter/Holder: Holberg EEG AS 510(K) Reference: K231068 No reference devices have been used in this submission. Page 1 of 19 === Pag… | 2024 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260998 | Ceribell Neurology Review Software | 2026 | 0 |
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 3 companies; a new generation was cleared every 4.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K260998 (Ceribell, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K171720.
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. 2025, 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?
autoSCORE is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices using scalp electrodes and to aid neurologists in the assessment of EEG. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information. The spike detection component of autoSCORE is intended to mark previously acquired sections of the patient’s EEG recordings…
Read the full statement (247 words)
autoSCORE is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices using scalp electrodes and to aid neurologists in the assessment of EEG. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.
The spike detection component of autoSCORE is intended to mark previously acquired sections of the patient’s EEG recordings that may correspond to spikes, in order to assist qualified clinical practitioners in the assessment of EEG traces. The spike detection component is intended to be used In patients at least three months old for EEGs <4 hours and at least two years old for EEGs >4 hours. The autoSCORE component has not been assessed for intracranial recordings.
autoSCORE is intended to assess the probability that previously acquired sections of EEG recordings contain abnormalities, and classifies these into pre-defined types of abnormalities, including epileptiform and non-epileptiform abnormalities.
autoSCORE does not have a user interface. autoSCORE sends this information to the EEG reviewing software to indicate where markers indicating abnormality are to be placed in the EEG. autoSCORE also provides the probability that EEG recordings include abnormalities and the type of abnormalities. The user is required to review the EEG and exercise their clinical judgement to independently make a conclusion supporting or not supporting brain disease.
This device does not provide any diagnostic conclusion about the patient's condition to the user. The device is not intended to detect or classify seizures.
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/K243743 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243743: autoSCORE (V 2.0.0).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243743
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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