510(k) · Cleared
ClearedREMI-AI Rapid Detection Module (REMI-AI RDM)
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 Oct 17, 2024 as substantially equivalent to K191301 (Ceribell, Inc., 2019) and 1 other predicate after a 251-day review. Its family tree reaches back 3 generations to 1983.
- Decided
- Oct 17, 2024
- Review
- 251 days
- Class
- Class II
- Product code
- OMB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K830295 (1983). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK830295 Medilog 9000 SystemOxford Medilog, Inc. · 1983
- 2 generations backK170363 Ceribell Pocket EEG DeviceCeribell, Inc. · 2017
- 1 generation backK191301 Ceribell Pocket EEG DeviceCeribell, Inc. · 2019
- This deviceK240408 REMI-AI Rapid Detection Module (REMI-AI RDM)Epitel, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K830295 | Medilog 9000 System | Oxford Medilog, Inc. | 1983 | — |
| −2 | K170363 | Ceribell Pocket EEG Device | Ceribell, Inc. | 2017 | — |
| −1 | K191301 | Ceribell Pocket EEG Device | Ceribell, Inc. | 2019 | — |
| 0 (this device) | K240408 | REMI-AI Rapid Detection Module (REMI-AI RDM) | Epitel, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K191301 | Ceribell Pocket EEG DeviceSummary page 5…n Number: OMB - Sec. 882.1400 3. Predicate Devices Predicate Type 510(k) Number Name of Device Name of Manufacturer Primary Predicate K191301 Ceribell Pocket EEG Ceribell, Inc. Device… | 2019 |
| * | K231779 | REMI AI Discrete Detection ModuleSummary page 5…G Ceribell, Inc. Device (Seizure Detection Module) Secondary K231779 REMI-AI Discrete Detection Epitel, Inc. Predicate Module (RDM) 4. Device Descrip… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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 5.1 years on median.
- None of the 6 ancestors has a recall.
- 4 other devices also cite its predicate K191301.
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 Rapid Detection Module (REMI-AI ROM) is a seizure detection module which is integrated into the REMI Remote EEG Monitoring System and is only indicated for use within non-ICU (Intensive Care Unit) healthcare settings. REMI-AI ROM has not been validated for and is not indicated for detection of electrographic status epilepticus. REMI-AI ROM conducts automated analysis of REMI EEG data in near real-time and provides notifications of potential…
Read the full statement (213 words)
The REMI-AI Rapid Detection Module (REMI-AI ROM) is a seizure detection module which is integrated into the REMI Remote EEG Monitoring System and is only indicated for use within non-ICU (Intensive Care Unit) healthcare settings. REMI-AI ROM has not been validated for and is not indicated for detection of electrographic status epilepticus.
REMI-AI ROM conducts automated analysis of REMI EEG data in near real-time and provides notifications of potential electrographic seizures (events) through the REMI System when seizure prevalence of 10% or greater (indicating seizure activity of at least 30 seconds within a 5-minute rolling window) is detected. When seizure prevalence is displayed, the notification also displays the corresponding event detection confidence. Notifications are intended to be used by qualified clinicians who will exercise professional judgment in their application. Detected events are also annotated in the associated REMI EEG record as an aide to the qualified physician's REMI EEG review.
Delays of up to several minutes may occur between the detection of an event and the generation of an event notification, and are thus not a substitute for real-time monitoring. REMI-AI ROM does not make any diagnostic conclusion about the subject's condition and is intended as a physiological signal monitor. REMI-AI ROM is indicated for use with adult and pediatric patients (6+ years).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240408 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240408: REMI-AI Rapid Detection Module (REMI-AI RDM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240408
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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