510(k) · Cleared
ClearedREMI AI Discrete Detection Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Epitel, Inc. · OMB Automatic Event Detection Software For Full-Montage Electroencephalograph
Cleared on Jan 3, 2024 as substantially equivalent to K182181 (Persyst Development Corporation, 2018) after a 201-day review. Its family tree reaches back 1 generation to 2018. 1 later device descends from it.
- Decided
- Jan 3, 2024
- Review
- 201 days
- Class
- Class II
- Product code
- OMB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K182181 (2018). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK182181 Persyst 14 EEG Review and Analysis SoftwarePersyst Development Corporation · 2018
- This deviceK231779 REMI AI Discrete Detection ModuleEpitel, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK240408 REMI-AI Rapid Detection Module (REMI-AI RDM)Epitel, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K240408REMI-AI Rapid Detection Module (REMI-AI RDM)Epitel, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K182181 | Persyst 14 EEG Review and Analysis Software | Persyst Development Corporation | 2018 | — |
| 0 (this device) | K231779 | REMI AI Discrete Detection Module | Epitel, Inc. | 2024 | — |
| +1 | K240408 | REMI-AI Rapid Detection Module (REMI-AI RDM) | Epitel, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (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 |
|---|---|---|---|
| * | K182181 | Persyst 14 EEG Review and Analysis SoftwareSummary page 5…Product Code and Regulation Number: OMB - Sec. 882.1400 3. Predicate Device Name of Device: Persyst 14 EEG Review and Analysis Software 510(k) Number: K182181 Manufacturer: Persyst Development Corporation 4. Device Description REMI-AI Discrete Detection Module (REMI-AI DDM) is a… | 2018 |
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 |
|---|---|---|---|
| K240408 | REMI-AI Rapid Detection Module (REMI-AI RDM) | 2024 | 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?
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?
The REMI-AI Discrete Detection Module (REMI-AI DDM) is indicated for the analysis of REMI Remote EEG Monitoring System electroencephalogram (EEG) recordings. REMI-AI DDM is intended to be used by physicians qualified to analyze and interpret EEG who will exercise professional judgment in using the information. As an aide to the qualified physician’s REMI EEG review, REMI-AI DDM marks previously acquired sections of REMI EEG that may correspond to…
Read the full statement (122 words)
The REMI-AI Discrete Detection Module (REMI-AI DDM) is indicated for the analysis of REMI Remote EEG Monitoring System electroencephalogram (EEG) recordings. REMI-AI DDM is intended to be used by physicians qualified to analyze and interpret EEG who will exercise professional judgment in using the information.
As an aide to the qualified physician’s REMI EEG review, REMI-AI DDM marks previously acquired sections of REMI EEG that may correspond to neurological events of interest indicative of potential electrographic seizures lasting at least 10 seconds in duration. REMI-AI DDM is indicated for use with adult and pediatric patients (6+ years).
REMI-AI DDM does not mark REMI EEG records in real time and does not provide any diagnostic conclusion about the patient's condition to the user.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231779 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231779: REMI AI Discrete Detection Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231779
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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