510(k) · Cleared
Clearedencevis (2.1)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ait Austrian Institute of Technology GmbH · OMB Automatic Event Detection Software For Full-Montage Electroencephalograph
Cleared on Sep 27, 2024 as substantially equivalent to K211452 (Austrian Institute of Technology GmbH, 2021) and 3 other predicates after a 169-day review. Its family tree reaches back 4 generations to 1983. 2 later devices descend from it.
- Decided
- Sep 27, 2024
- Review
- 169 days
- Class
- Class II
- Product code
- OMB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K830295 (1983). 8 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK830295 Medilog 9000 SystemOxford Medilog, Inc. · 1983
- 3 generations backK170363 Ceribell Pocket EEG DeviceCeribell, Inc. · 2017
- 2 generations backK191301 Ceribell Pocket EEG DeviceCeribell, Inc. · 2019
- 1 generation backK223504 Ceribell Status Epilepticus MonitorCeribell, Inc. · 2023
- This deviceK240993 encevis (2.1)Ait Austrian Institute of Technology GmbH · 2024
- Descendant · cites it directly · 0 of its ownK261712 Ceribell EEG Analysis SoftwareCeribell, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK260998 Ceribell Neurology Review SoftwareCeribell, Inc. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K830295 | Medilog 9000 System | Oxford Medilog, Inc. | 1983 | — |
| −3 | K170363 | Ceribell Pocket EEG Device | Ceribell, Inc. | 2017 | — |
| −2 | K191301 | Ceribell Pocket EEG Device | Ceribell, Inc. | 2019 | — |
| −1 | K223504 | Ceribell Status Epilepticus Monitor | Ceribell, Inc. | 2023 | — |
| 0 (this device) | K240993 | encevis (2.1) | Ait Austrian Institute of Technology GmbH | 2024 | — |
| +1 | K261712 | Ceribell EEG Analysis Software | Ceribell, Inc. | 2026 | — |
| +1 | K260998 | Ceribell Neurology Review Software | Ceribell, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 2 | 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 K260998 Ceribell Neurology Review Softwarescore 12.8 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K211452 | EncevisSummary page 8…Page 2 of 37 Encevis 2.0 - 510_k_ summary (Rev. 310967) 4 Legally Marketed Predicate Devices Primary Predicate: K211452 encevis 1.12 Review and Analysis Software Additional K132306 Persyst 12 EEG Review and Analysis Software Pred… | 2021 |
| * | K132306 | Persyst 12 Eeg Review and Analysis SoftwareSummary page 8…mmary (Rev. 310967) 4 Legally Marketed Predicate Devices Primary Predicate: K211452 encevis 1.12 Review and Analysis Software Additional K132306 Persyst 12 EEG Review and Analysis Software Predicate: Additional K223504 Ceribell Status Epilepticus Monitor… | 2013 |
| * | K223504 | Ceribell Status Epilepticus MonitorSummary page 8…1452 encevis 1.12 Review and Analysis Software Additional K132306 Persyst 12 EEG Review and Analysis Software Predicate: Additional K223504 Ceribell Status Epilepticus Monitor Predicate: Additional K191301 Ceribell Pocket EEG Device Predicate:… | 2023 |
| * | K191301 | Ceribell Pocket EEG DeviceSummary page 8…rsyst 12 EEG Review and Analysis Software Predicate: Additional K223504 Ceribell Status Epilepticus Monitor Predicate: Additional K191301 Ceribell Pocket EEG Device Predicate: 5 Device description encevis combines several modalities for viewing and analyzing… | 2019 |
What descends from it? (2)
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 41 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K261712 (Ceribell, Inc., 2026) has gone furthest, with 0 descendants of its own.
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. 2024, 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?
1. encevis 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. 2. The seizure detection component of encevis is intended to mark previously acquired sections of adult (greater than or…
Read the full statement (730 words)
1. encevis 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.
2. The seizure detection component of encevis is intended to mark previously acquired sections of adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic seizures, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with a full scalp montage according to the standard 10/20-system.
3. The spike detection component of encevis 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 adult patients greater than or equal to 18 years. encevis Spike detection performance has not been assessed for intracranial recordings.
4. encevis includes the calculation and display of a set of quantitative measures intended to monitor and analyze the EEG waveform. These include frequency bands, rhythmic and periodic patterns, burst suppression and spectrogram. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG waveforms.
5. The aEEG functionality included in encevis is intended to monitor the state of the brain.
6. encevis provides notifications on an on-screen display for seizure detection, electrographic status epilepticus detection, spike detection, quantitative EEG and aEEG that can be used when processing a record during acquisition (online) or based on stored EEG files (offline). Notifications can also be provided to external systems via the external interfaces to make them accessible to the user through the external system in a human-readable format. Delays of up to several minutes can occur between the beginning of a seizure, electrographic status epilepticus, the occurrence of a spike or detection of quantitative EEG features and when the encevis notifications will be shown to a user. encevis notifications cannot be used as a substitute for real time monitoring of the underlying EEG by a trained expert.
7. encevis PureEEG (Artifact Reduction) is intended to reduce EMG and electrode artifacts in a standard 10-20 EEG recording. PureEEG does not remove the entire artifact signal and is not effective for other types of artifacts. PureEEG may modify portions of waveforms representing cerebral activity. Waveforms must still be read by a qualified medical practitioner trained in recognizing artifact, and any interpretation or diagnosis must be made with reference to the original waveforms.
8. This device does not provide any diagnostic conclusion about the patient's condition to the user.
9. The encevis Component for Detection of Seizures and Electrographic Status Epilepticus is indicated for the detection of Seizures and Electrographic Status Epilepticus in patients greater than or equal to 18 years of age who are at risk for seizures. The Component for Detection of Seizures and Electrographic Status Epilepticus of encevis analyzes EEG waveforms and identifies patterns that may be consistent with seizures and electrographic status epilepticus as defined in the American Clinical Neurophysiology Society's Guideline 14. EEG recordings should be obtained with a full scalp montage according to the standard 10/20-system. The diagnostic output does also include a measure of seizure prevalence ("seizure burden") within a 10 minute (short-term seizure burden) and a 60 minute (hourly seizure burden) moving window. The output of the Component for Detection of Seizures and Electrographic Status Epilepticus of encevis is intended to be used as a diagnostic output for determining patient treatment in acute-care environments. Detections from the Component for Detection of Seizures and Electrographic Status Epilepticus of encevis provide one input to the clinician that is intended to be used in conjunction with other elements of clinical practice to determine the appropriate treatment course for the patient. The Component for Detection of Seizures and Electrographic Status Epilepticus of encevis is intended for detection of electrographic status epilepticus only. The Component for Detection of Seizures and Electrographic Status Epilepticus of encevis does not substitute for the review of the underlying EEG by a qualified clinician with respect to any other types of pathological EEG patterns. The Component for Detection of Seizures and Electrographic Status Epilepticus of encevis is not intended for use in Epilepsy Monitoring Units.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240993 · printed Nov 3, 2026
Cite this page
510(k) Report. “K240993: encevis (2.1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K240993
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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