510(k) · Cleared
ClearedPersyst 12 Eeg Review and Analysis Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Persyst Development Corp. · OMB Automatic Event Detection Software For Full-Montage Electroencephalograph
Cleared on Nov 21, 2013 after a 120-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 11 later devices descend from it.
- Decided
- Nov 21, 2013
- Review
- 120 days
- Class
- Class II
- Product code
- OMB
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 5 citing it directly.
- This deviceK132306 Persyst 12 Eeg Review and Analysis SoftwarePersyst Development Corp. · 2013
- Descendant · cites it directly · 6 of its ownK171720 encevisAit Austrian Institute of Technology GmbH · 2018
- Descendant · cites it directly · 3 of its ownK211452 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 · 2 of its ownK231068 autoSCOREHolberg Eeg AS · 2024
- Descendant · 2 generations on · 1 of its ownK243743 autoSCORE (V 2.0.0)Holberg Eeg AS · 2025
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K171720encevisAit Austrian Institute of Technology GmbH · 2018 · cites it directly6descendants
- K211452EncevisAustrian Institute of Technology GmbH · 2021 · cites it directly3descendants
- K240993encevis (2.1)Ait Austrian Institute of Technology GmbH · 2024 · cites it directly2descendants
- K231068autoSCOREHolberg Eeg AS · 2024 · 2 generations on2descendants
- K243743autoSCORE (V 2.0.0)Holberg Eeg AS · 2025 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K132306 | Persyst 12 Eeg Review and Analysis Software | Persyst Development Corp. | 2013 | — |
| +1 | K171720 | encevis | Ait Austrian Institute of Technology GmbH | 2018 | — |
| +1 | K211452 | Encevis | Austrian Institute of Technology GmbH | 2021 | — |
| +1 | K240993 | encevis (2.1) | Ait Austrian Institute of Technology GmbH | 2024 | — |
| +2 | K231068 | autoSCORE | Holberg Eeg AS | 2024 | — |
| +2 | K243743 | autoSCORE (V 2.0.0) | Holberg Eeg AS | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (11)
See all 115 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?
- Of its descendants, K171720 (Ait Austrian Institute of Technology GmbH, 2018) has gone furthest, with 6 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. 2013, 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. Persyst 12 EEG Review and Analysis Software 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 Persyst 12 is intended to mark previously acquired…
Read the full statement (450 words)
1. Persyst 12 EEG Review and Analysis Software 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 Persyst 12 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 Persyst 12 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 one month old. Persyst 12 Spike Detection performance has not been assessed for intracranial recordings.
4. Persyst 12 includes the calculation and display of a set of quantitative measures intended to monitor and analyze the EEG waveform. These include FIFT, Rhythmicity, Peak Envelope, Artifact Intensity, Amplitude, Relative Symmetry and Suppression Ratio. Automatic event marking is not applicable to the quantitative measures. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG waveforms.
5. The aEEG functionality included in Persyst 12 is intended to monitor the state of the brain. The automated event marking function of Persyst 12 is not applicable to aEEG.
6. Persyst 12 provides notifications for seizure detection, quantitative EEG and aEEG that can be used when processing a record during acquisition. These include an on screen display and the optional sending of an email message. Delays of up to several minutes can occur between the beginning of a seizure and when the Persyst 12 notifications will be shown to a user. Persyst 12 notifications cannot be used as a substitute for real time monitoring of the underlying EEG by a trained expert.
7. Persyst AR (Artifact Reduction) is intended to reduce EMG, eye movement, and electrode artifacts in a standard 10-20 EEG recording. 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 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 as stated in the FDA 510(k) statement.
https://510kreport.com/device/K132306 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132306: Persyst 12 Eeg Review and Analysis Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132306
Report an extraction error
Are you the manufacturer?
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