510(k) · Cleared
ClearedEncevis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Austrian Institute of Technology GmbH · OMB Automatic Event Detection Software For Full-Montage Electroencephalograph
Cleared on Dec 2, 2021 as substantially equivalent to K132306 (Persyst Development Corp., 2013) and 1 other predicate after a 206-day review. Its family tree reaches back 2 generations to 2013. 3 later devices descend from it.
- Decided
- Dec 2, 2021
- Review
- 206 days
- Class
- Class II
- Product code
- OMB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K132306 (2013). 3 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK132306 Persyst 12 Eeg Review and Analysis SoftwarePersyst Development Corp. · 2013
- 1 generation backK171720 encevisAit Austrian Institute of Technology GmbH · 2018
- This deviceK211452 EncevisAustrian Institute of Technology GmbH · 2021
- Descendant · cites it directly · 2 of its ownK240993 encevis (2.1)Ait Austrian Institute of Technology GmbH · 2024
- Descendant · 2 generations on · 0 of its ownK261712 Ceribell EEG Analysis SoftwareCeribell, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK260998 Ceribell Neurology Review SoftwareCeribell, Inc. · 2026
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K132306 | Persyst 12 Eeg Review and Analysis Software | Persyst Development Corp. | 2013 | — |
| −1 | K171720 | encevis | Ait Austrian Institute of Technology GmbH | 2018 | — |
| 0 (this device) | K211452 | Encevis | Austrian Institute of Technology GmbH | 2021 | — |
| +1 | K240993 | encevis (2.1) | Ait Austrian Institute of Technology GmbH | 2024 | — |
| +2 | K261712 | Ceribell EEG Analysis Software | Ceribell, Inc. | 2026 | — |
| +2 | 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 |
|---|---|---|
| 2024 | 1 | 0 |
| 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 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 |
|---|---|---|---|
| * | K132306 | Persyst 12 Eeg Review and Analysis SoftwareSummary page 6…de: OMB, OLT, OMA Class: II Panel: Neurology 4. Legally Marketed Predicate Devices Primary Predicate: K132306 Persyst 12 EEG Review and Analysis Software Additional Predicate: K171720 encevis 1.6… | 2013 |
| * | K171720 | encevisSummary page 6…Neurology 4. Legally Marketed Predicate Devices Primary Predicate: K132306 Persyst 12 EEG Review and Analysis Software Additional Predicate: K171720 encevis 1.6 510(k) summary – Page 2 Traditional 510(… | 2018 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240993 | encevis (2.1) | 2024 | 2 |
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 8 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K240993 (Ait Austrian Institute of Technology GmbH, 2024) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K132306.
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. 2021, 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 (413 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 and burst suppression. 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, spike detection, quantitative EEG and aEEG that can be used when processing a record during acquisition. Delays of up to several minutes can occur between the beginning of a seizure, 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.
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/K211452 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211452: Encevis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211452
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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